5,876 Senior Pharmaceutical Quality Control Analyst Remote jobs in Kenya
Senior Pharmaceutical Quality Control Analyst (No Remote)
Posted 21 days ago
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Job Description
Our client, a leading pharmaceutical company, is seeking a highly meticulous and experienced Senior Pharmaceutical Quality Control Analyst to join their on-site laboratory team. This critical role ensures that all manufactured pharmaceutical products meet stringent quality standards and regulatory requirements. You will be responsible for performing a wide range of analytical tests on raw materials, in-process samples, and finished products using advanced laboratory equipment and techniques. The ideal candidate will possess a deep understanding of pharmaceutical analytical chemistry, Good Manufacturing Practices (GMP), and relevant regulatory guidelines (e.g., FDA, ICH). Your duties will include method development and validation, instrument calibration and maintenance, data interpretation, and thorough documentation of all experimental procedures and results. You will also play a key role in troubleshooting analytical issues, investigating deviations, and contributing to continuous improvement initiatives within the quality control department. Collaboration with R&D, manufacturing, and regulatory affairs teams is essential. This position demands exceptional attention to detail, strong problem-solving skills, and a commitment to upholding the highest standards of quality and safety in pharmaceutical production. This is an excellent opportunity for a dedicated analytical chemist to contribute to the development and release of life-saving medications.
Responsibilities:
Responsibilities:
- Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, Karl Fischer titration).
- Develop, validate, and transfer analytical methods according to regulatory requirements.
- Operate, calibrate, and maintain laboratory equipment to ensure accuracy and reliability.
- Interpret analytical data, identify out-of-specification (OOS) results, and conduct investigations.
- Document all laboratory activities, results, and deviations in compliance with GMP and GxP guidelines.
- Prepare Certificates of Analysis (CoA) and technical reports.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs.
- Participate in internal and external audits.
- Contribute to process improvements and the implementation of new technologies in the QC lab.
- Ensure a safe working environment and adherence to all safety protocols.
- Mentor and train junior QC analysts.
- Stay current with relevant pharmacopoeias and regulatory updates.
- Bachelor's degree or Master's degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
- Minimum of 5 years of hands-on experience in pharmaceutical quality control or analytical development.
- Extensive experience with analytical instrumentation such as HPLC, GC, and spectrophotometers.
- Thorough understanding of GMP, ICH guidelines, and pharmacopoeial standards (e.g., USP, EP).
- Proficiency in method development, validation, and troubleshooting.
- Strong data interpretation and analytical skills.
- Excellent documentation and report-writing abilities.
- Meticulous attention to detail and commitment to accuracy.
- Good laboratory practices (GLP) knowledge is a plus.
- Effective communication and teamwork skills.
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Senior Pharmaceutical Quality Control Analyst - Remote
Posted 20 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to advancing healthcare, is seeking a highly experienced Senior Pharmaceutical Quality Control Analyst to join their esteemed team. This pivotal role will operate on a fully remote basis, ensuring the integrity and compliance of our pharmaceutical products. You will be responsible for executing a wide range of analytical tests, interpreting results, and maintaining meticulous documentation according to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Key duties include performing assays, stability testing, impurity profiling, and method validation using various sophisticated analytical instruments such as HPLC, GC, UV-Vis spectrophotometry, and Karl Fischer titrators. You will play a crucial role in identifying deviations from specifications, investigating out-of-specification (OOS) results, and contributing to corrective and preventive actions (CAPA). The ideal candidate will possess a strong academic background in Chemistry, Pharmacy, or a related life science discipline, coupled with extensive hands-on experience in pharmaceutical quality control. Proficiency with pharmacopeial methods (USP, EP, BP) is essential. This is a fully remote position, requiring exceptional organizational skills, self-motivation, and the ability to manage laboratory data and reports accurately from a remote location. You must possess excellent analytical thinking, attention to detail, and strong written and verbal communication skills to effectively document findings and collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs. The ability to work independently and as a proactive member of a virtual team is paramount. You will contribute significantly to ensuring product quality and patient safety. This role offers an exciting opportunity to apply your expertise in a critical area of pharmaceutical development and manufacturing, all within a flexible remote work setting. Your insights will directly impact product release and regulatory submissions.
Responsibilities:
Responsibilities:
- Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products.
- Execute method validation and transfer protocols.
- Operate and maintain analytical instrumentation (HPLC, GC, UV-Vis, KF).
- Interpret analytical data and prepare detailed test reports.
- Investigate out-of-specification (OOS) and out-of-trend (OOT) results.
- Contribute to the development and implementation of CAPAs.
- Ensure compliance with GLP, GMP, and relevant pharmacopeial standards.
- Review and approve analytical batch records.
- Collaborate with R&D, manufacturing, and regulatory teams.
- Participate in internal and external audits.
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related life science field.
- Minimum of 6 years of experience in pharmaceutical quality control/assurance.
- Extensive experience with analytical techniques (HPLC, GC, spectroscopy).
- Proficiency in pharmacopeial methods (USP, EP, BP).
- Strong understanding of GLP and GMP regulations.
- Excellent data analysis and problem-solving skills.
- Meticulous attention to detail and strong documentation abilities.
- Effective written and verbal communication skills.
- Proven ability to work independently and manage tasks in a remote environment.
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Senior Quality Control Specialist - Remote
Posted 13 days ago
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Job Description
Our client is seeking a meticulous and experienced Senior Quality Control Specialist to join their dedicated team in a fully remote capacity. This role is crucial for ensuring the highest standards of cleanliness and sanitation across various environments managed by our client. You will be responsible for developing, implementing, and monitoring comprehensive quality control programs and procedures related to cleaning and sanitation services. This includes establishing clear protocols, performance metrics, and audit processes to guarantee compliance and effectiveness. Your duties will involve conducting remote assessments, analyzing inspection reports, and identifying areas where quality may fall short. You will work closely with on-site cleaning teams and management (virtually) to provide guidance, training, and support to ensure adherence to established standards. This requires excellent communication and training skills, as you will guide others in maintaining impeccable hygiene. You will also be responsible for investigating quality deviations, determining root causes, and recommending corrective and preventive actions. Developing and updating training materials and manuals related to cleaning techniques, safety protocols, and regulatory compliance will be a key part of the role. Staying current with industry best practices, emerging technologies, and relevant health and safety regulations is essential. The ideal candidate will possess a strong understanding of sanitation science, infection control principles, and quality management systems. As a remote position, strong self-management, analytical abilities, and the capacity to effectively communicate and influence without direct physical oversight are critical. You will be a key advocate for maintaining exceptional standards of cleanliness and safety.
Key Responsibilities:
Key Responsibilities:
- Develop and implement quality control programs for cleaning and sanitation services.
- Establish performance metrics, standards, and audit procedures.
- Conduct remote assessments and analyze inspection reports.
- Provide virtual guidance, training, and support to on-site teams.
- Investigate quality issues, identify root causes, and recommend corrective actions.
- Develop and update training materials on sanitation best practices and safety.
- Ensure compliance with health, safety, and environmental regulations.
- Stay informed about industry trends and new cleaning technologies.
- Maintain comprehensive records of quality control activities and findings.
- Collaborate with management to continuously improve sanitation standards.
- Proven experience in quality control, preferably within the cleaning, sanitation, or facilities management industry.
- Strong knowledge of sanitation principles, cleaning methods, and infection control.
- Experience in developing and implementing quality management systems (QMS).
- Excellent analytical and problem-solving skills.
- Strong communication, training, and presentation skills.
- Ability to effectively manage and guide remote teams.
- Proficiency in using digital tools for reporting and communication.
- Certification in relevant quality management or sanitation fields is a plus.
- Bachelor's degree in a relevant field or equivalent work experience.
- Detail-oriented with a strong commitment to maintaining high standards.
This advertiser has chosen not to accept applicants from your region.
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Remote Pharmaceutical Quality Assurance Specialist (Remote)
Posted 22 days ago
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Job Description
Join our client's dedicated team as a Remote Pharmaceutical Quality Assurance Specialist. This is a unique opportunity for a meticulous and experienced professional to contribute to ensuring the highest standards of quality and compliance within the pharmaceutical industry, all from a remote work environment. You will play a critical role in maintaining the integrity of our client's products by overseeing and implementing robust quality assurance processes. This fully remote position requires a strong understanding of regulatory requirements, manufacturing processes, and quality control methodologies within the pharmaceutical sector. Your responsibilities will include developing, implementing, and maintaining quality management systems; conducting internal audits and inspections to ensure compliance with GMP, GDP, and other relevant regulations; reviewing and approving documentation, such as batch records, SOPs, and validation reports; investigating deviations, CAPAs, and non-conformances, and implementing corrective and preventive actions; collaborating with cross-functional teams, including manufacturing, R&D, and regulatory affairs, to address quality issues; monitoring key quality metrics and preparing reports for management; and staying abreast of evolving regulatory landscapes and industry best practices. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. Significant experience in pharmaceutical quality assurance, quality control, or regulatory affairs is essential. Comprehensive knowledge of cGMP (current Good Manufacturing Practices) and other international quality standards is required. Strong analytical, problem-solving, and documentation skills are paramount. Excellent written and verbal communication abilities are necessary for effective collaboration and reporting in a virtual setting. This role demands a self-motivated individual with a proven ability to work independently, manage time effectively, and maintain meticulous records. A reliable internet connection and a suitable, distraction-free home office environment are mandatory. If you are a seasoned QA professional dedicated to upholding pharmaceutical excellence and thrive in a remote work setting, we invite you to apply.
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Senior Pharmaceutical Quality Assurance Analyst - Remote
Posted 20 days ago
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Job Description
Our client, a leading pharmaceutical innovator, is looking for a highly skilled Senior Pharmaceutical Quality Assurance Analyst to join their dynamic team. This is a fully remote position, offering the flexibility to work from anywhere while contributing to the critical work of ensuring product quality and compliance within the pharmaceutical industry. The successful candidate will be instrumental in developing, implementing, and maintaining robust quality assurance systems and processes that adhere to stringent regulatory requirements, including GMP (Good Manufacturing Practices) and relevant international standards.
Key responsibilities will involve conducting in-depth reviews of batch records, analytical data, and validation reports to ensure accuracy, completeness, and compliance. You will be responsible for investigating deviations, out-of-specification (OOS) results, and customer complaints, performing root cause analysis, and recommending corrective and preventive actions (CAPAs). This role requires significant interaction with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure quality is integrated throughout the product lifecycle. You will also participate in internal and external audits, providing support and ensuring readiness for regulatory inspections.
Furthermore, the Senior Pharmaceutical Quality Assurance Analyst will contribute to the development and improvement of quality management systems, standard operating procedures (SOPs), and training programs. You will be expected to stay abreast of evolving regulatory landscapes and industry best practices, providing guidance and expertise to project teams. A key aspect of this role involves risk assessment and management related to product quality and manufacturing processes. The ability to manage multiple projects simultaneously, meet strict deadlines, and maintain a high level of detail is essential. This remote position requires strong analytical, critical thinking, and communication skills. While the role is remote, a deep understanding of pharmaceutical operations, including those potentially serving the **Machakos, Machakos, KE** region or similar, is vital for context and effective collaboration.
Key responsibilities will involve conducting in-depth reviews of batch records, analytical data, and validation reports to ensure accuracy, completeness, and compliance. You will be responsible for investigating deviations, out-of-specification (OOS) results, and customer complaints, performing root cause analysis, and recommending corrective and preventive actions (CAPAs). This role requires significant interaction with cross-functional teams, including R&D, manufacturing, regulatory affairs, and supply chain, to ensure quality is integrated throughout the product lifecycle. You will also participate in internal and external audits, providing support and ensuring readiness for regulatory inspections.
Furthermore, the Senior Pharmaceutical Quality Assurance Analyst will contribute to the development and improvement of quality management systems, standard operating procedures (SOPs), and training programs. You will be expected to stay abreast of evolving regulatory landscapes and industry best practices, providing guidance and expertise to project teams. A key aspect of this role involves risk assessment and management related to product quality and manufacturing processes. The ability to manage multiple projects simultaneously, meet strict deadlines, and maintain a high level of detail is essential. This remote position requires strong analytical, critical thinking, and communication skills. While the role is remote, a deep understanding of pharmaceutical operations, including those potentially serving the **Machakos, Machakos, KE** region or similar, is vital for context and effective collaboration.
This advertiser has chosen not to accept applicants from your region.
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Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 7 days ago
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Job Description
Our client is seeking a highly skilled and experienced Lead Pharmaceutical Regulatory Affairs Specialist to join their dynamic, fully remote team. This role is crucial for navigating the complex regulatory landscape of pharmaceutical product development, approval, and lifecycle management. You will be responsible for developing and implementing regulatory strategies, preparing and submitting comprehensive regulatory dossiers, and ensuring compliance with national and international regulations (e.g., FDA, EMA, WHO). The ideal candidate will possess a strong understanding of pharmaceutical science, clinical trial processes, and regulatory submission requirements. Experience in managing regulatory submissions for various product types (e.g., generics, biologics, new molecular entities) is essential. You will serve as a key liaison between the company and regulatory authorities, responding to inquiries and addressing regulatory challenges. This position requires exceptional analytical, communication, and project management skills, with the ability to lead a team and mentor junior specialists. As a remote-first role, you will need to be highly self-motivated, detail-oriented, and capable of managing multiple complex projects concurrently in a virtual environment. Your expertise will be vital in ensuring that our client's products reach patients safely and effectively. While the position is fully remote, it is integral to our client's operations and regulatory compliance efforts concerning products that impact the **Bungoma, Bungoma, KE** region and beyond. You will be a strategic partner in accelerating product development timelines and maintaining market access. If you are a seasoned regulatory affairs professional with a proven track record in the pharmaceutical industry and excel in a remote, collaborative setting, we invite you to apply.
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5
Lead Pharmaceutical QA/QC Specialist (Remote)
Posted 21 days ago
Job Viewed
Job Description
Our client, a dynamic pharmaceutical company, is seeking a dedicated and experienced Lead Pharmaceutical QA/QC Specialist to manage and enhance quality assurance and quality control processes from a fully remote position. This critical role involves ensuring that all pharmaceutical products meet stringent quality standards and regulatory requirements throughout their lifecycle. You will be responsible for developing, implementing, and maintaining robust quality systems, overseeing testing procedures, and ensuring compliance with cGMP and other relevant guidelines. This position is perfect for a meticulous professional who excels in a remote work environment and can lead quality initiatives effectively.
Responsibilities:
Qualifications:
This is a significant opportunity to lead quality initiatives and ensure the highest standards in pharmaceutical manufacturing, all within a remote work structure. You will play a crucial role in safeguarding product integrity and patient safety, contributing to operations relevant to **Nyeri, Nyeri, KE**, and the broader pharmaceutical landscape, as a valued member of our remote-first organization.
Responsibilities:
- Develop, implement, and maintain comprehensive Quality Assurance (QA) and Quality Control (QC) systems.
- Oversee the execution of analytical testing for raw materials, in-process samples, and finished products.
- Ensure compliance with cGMP, ICH guidelines, and other relevant regulatory standards.
- Write, review, and approve Standard Operating Procedures (SOPs), batch records, and validation protocols.
- Manage deviations, Out-of-Specification (OOS) results, and CAPA investigations.
- Conduct internal audits and support external regulatory inspections.
- Train and mentor QA/QC personnel.
- Analyze quality data to identify trends and implement continuous improvement initiatives.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure product quality and compliance.
- Stay current with evolving regulatory requirements and industry best practices in pharmaceutical quality management.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline. M.Sc. or Ph.D. is a plus.
- Minimum of 7 years of progressive experience in pharmaceutical Quality Assurance and/or Quality Control.
- In-depth knowledge of cGMP regulations, ICH guidelines, and pharmaceutical manufacturing processes.
- Proven experience in managing analytical testing, method validation, and stability studies.
- Strong understanding of quality management systems, including deviation management, CAPA, and change control.
- Excellent documentation, analytical, and problem-solving skills.
- Strong leadership and team management capabilities.
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote setting.
- Experience with electronic quality management systems (eQMS) is beneficial.
- Detail-oriented with a strong commitment to quality and compliance.
This is a significant opportunity to lead quality initiatives and ensure the highest standards in pharmaceutical manufacturing, all within a remote work structure. You will play a crucial role in safeguarding product integrity and patient safety, contributing to operations relevant to **Nyeri, Nyeri, KE**, and the broader pharmaceutical landscape, as a valued member of our remote-first organization.
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6
Principal Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 22 days ago
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Job Description
Our client, a leading player in the pharmaceutical industry, is seeking an exceptionally experienced Principal Pharmaceutical Regulatory Affairs Specialist to join their globally distributed team. This is a fully remote position, offering the unique opportunity to work from your location within Kenya and significantly influence global regulatory strategies. You will be the primary point of contact for regulatory submissions and interactions with health authorities worldwide. Your expertise will guide the company through complex regulatory landscapes, ensuring compliance with international guidelines and standards. Key responsibilities include developing regulatory strategies for new drug applications (NDAs), variations, and lifecycle management; preparing and submitting high-quality dossiers to regulatory agencies; and assessing regulatory risks and opportunities. You will collaborate closely with R&D, clinical development, manufacturing, and commercial teams to ensure alignment between regulatory requirements and business objectives. The ideal candidate will have a profound understanding of pharmaceutical product development, a comprehensive knowledge of global regulatory requirements (FDA, EMA, WHO, etc.), and a proven track record of successful regulatory submissions and approvals. Excellent analytical, strategic thinking, and communication skills are paramount. As this is a remote role, you must be highly self-disciplined, proactive, and adept at managing complex projects and cross-functional teams virtually. While the company operates globally, this role supports strategic alignment that may impact operations or research initiatives related to **Embu, Embu, KE**, but your work will be entirely remote.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Serve as the primary liaison with regulatory agencies, responding to queries and managing submissions.
- Assess regulatory risks and provide strategic guidance to project teams.
- Interpret and apply global regulatory guidelines and advise on compliance matters.
- Collaborate with R&D, Clinical, CMC, and Commercial teams to ensure regulatory requirements are met.
- Monitor changes in the regulatory landscape and advise the organization on strategic implications.
- Lead regulatory due diligence activities for potential acquisitions or partnerships.
- Mentor and guide junior regulatory affairs professionals.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Advanced degree (PharmD, PhD, MSc) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements and submission processes (e.g., FDA, EMA, ICH).
- Proven track record of successful IND, NDA, and/or MAA submissions and approvals.
- Exceptional strategic thinking, analytical, and problem-solving skills.
- Outstanding written and verbal communication and presentation skills.
- Demonstrated leadership capabilities and experience managing complex projects.
- Ability to work effectively independently and in a virtual, cross-functional team environment.
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7
Senior Quality Control Analyst (Pharmaceuticals) - Remote
Posted 20 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and experienced Senior Quality Control Analyst specializing in pharmaceuticals to join their dedicated remote team. This critical role involves ensuring the highest standards of quality and compliance for all manufactured pharmaceutical products. You will be responsible for developing, validating, and implementing analytical methods, conducting rigorous testing, and interpreting results to guarantee product integrity. This is an excellent opportunity to leverage your expertise in quality assurance within a flexible, home-based work setting. Your contributions will directly impact patient safety and product efficacy.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop, validate, and optimize analytical methods for raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, spectroscopy, and titrimetry.
- Perform routine quality control testing according to established protocols and specifications.
- Analyze and interpret test results, identifying any deviations or out-of-specification (OOS) findings.
- Investigate OOS results, implement corrective and preventive actions (CAPAs), and document all findings thoroughly.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and relevant regulatory guidelines (e.g., FDA, EMA).
- Maintain and calibrate laboratory equipment, ensuring its proper functioning and adherence to calibration schedules.
- Prepare Certificates of Analysis (CoA) and other quality-related documentation.
- Participate in internal and external audits, providing necessary information and demonstrating compliance.
- Train and mentor junior QC analysts on analytical techniques, procedures, and compliance requirements.
- Contribute to continuous improvement initiatives within the Quality Control department.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
- A minimum of 5 years of experience in pharmaceutical quality control, with a strong understanding of analytical techniques.
- Extensive hands-on experience with analytical instrumentation (HPLC, GC, UV-Vis, FTIR, etc.).
- In-depth knowledge of GMP, GLP, and regulatory requirements for pharmaceutical manufacturing.
- Proven experience in method validation and OOS investigations.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent attention to detail and organizational abilities.
- Proficiency in documentation and report writing.
- Ability to work independently and manage workload effectively in a remote environment.
- Familiarity with pharmaceutical manufacturing processes relevant to **Kakamega, Kakamega, KE** or similar regions is a plus.
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8
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 22 days ago
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Job Description
Our client, a forward-thinking pharmaceutical company, is seeking a highly skilled and experienced Senior Pharmaceutical Regulatory Affairs Specialist to oversee their global regulatory compliance efforts. This is a fully remote position, offering the flexibility to work from anywhere while ensuring critical regulatory standards are met. The Specialist will be responsible for developing and implementing regulatory strategies for product registration, lifecycle management, and post-market surveillance across various international markets. You will interpret and apply complex regulatory guidelines from agencies such as the FDA, EMA, and other global health authorities. Your duties will include preparing and submitting regulatory dossiers, responding to agency inquiries, and ensuring that all company activities adhere to relevant regulations and guidelines. The ideal candidate will have a strong scientific background (e.g., Pharmacy, Chemistry, Biology) and a proven track record in pharmaceutical regulatory affairs, with a minimum of 5-7 years of experience. In-depth knowledge of international regulatory submission processes (e.g., CTD, eCTD) and a thorough understanding of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) are essential. Experience with specific therapeutic areas or product types is a plus. This role requires exceptional attention to detail, strong analytical skills, and excellent written and verbal communication abilities. You must be proficient in using regulatory information management systems and other relevant software. As this is a remote role, the ability to work independently, manage priorities effectively, and collaborate virtually with cross-functional teams (R&D, Quality Assurance, Manufacturing) is crucial. You will be expected to stay current with evolving regulatory landscapes and provide expert guidance to internal stakeholders. This is an excellent opportunity to contribute to the development and accessibility of life-saving medications while enjoying the autonomy and flexibility of a remote career. The successful candidate will be a key player in navigating the complex regulatory pathways of the pharmaceutical industry, ensuring compliance and facilitating market access for innovative therapies. Your expertise will be vital in shaping regulatory strategies and ensuring the integrity of our client's product portfolio, all from your chosen remote location. The ability to proactively identify and mitigate regulatory risks will be a hallmark of your contribution, making you an indispensable asset to the team.
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