753 Pharmaceutical Regulatory Affairs Specialist jobs in Kenya
Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist. This is a fully remote position, offering the flexibility to work from anywhere while contributing to critical regulatory submissions and strategies. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations. This includes preparing, compiling, and submitting regulatory dossiers for new drug applications, variations, and post-approval changes. The ideal candidate will possess a deep understanding of regulatory requirements across various markets, exceptional attention to detail, and strong scientific writing skills. You will liaise with regulatory authorities, manage submission timelines, and stay abreast of evolving regulatory landscapes. This role requires a proactive approach to identifying potential regulatory challenges and developing effective solutions. Collaboration with R&D, manufacturing, and quality assurance teams will be integral to your success. We are seeking an individual with a strong scientific background and a proven ability to navigate complex regulatory frameworks. If you are passionate about ensuring patient access to safe and effective medicines through expert regulatory guidance, this is an exceptional opportunity. This fully remote role supports operations relevant to the Naivasha, Nakuru, KE region.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for product registrations, variations, and renewals in accordance with global regulatory guidelines.
- Maintain a thorough understanding of current and emerging pharmaceutical regulations and guidelines in target markets.
- Liaise with national and international health authorities on regulatory submissions and inquiries.
- Assess the regulatory implications of product changes, manufacturing processes, and quality systems.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure compliance with labeling requirements and review promotional materials for regulatory accuracy.
- Manage the lifecycle of regulatory approvals and maintain regulatory documentation.
- Conduct regulatory intelligence activities to identify new requirements and opportunities.
- Participate in regulatory audits and inspections as required.
- Develop and implement regulatory strategies to support product development and lifecycle management.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A higher degree or specialized certifications in Regulatory Affairs are highly desirable.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD, eCTD).
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Excellent scientific writing, analytical, and problem-solving skills.
- Strong attention to detail and accuracy.
- Effective communication and interpersonal skills, with the ability to collaborate with diverse teams.
- Proficiency in regulatory information management systems and standard office software.
- Ability to work independently and manage multiple projects in a remote setting.
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Lead Pharmaceutical Regulatory Affairs Specialist
Posted 16 days ago
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Job Description
Our client is seeking a highly experienced and strategic Lead Pharmaceutical Regulatory Affairs Specialist to join their fully remote global team. This pivotal role will oversee the regulatory strategy and execution for pharmaceutical products, ensuring compliance with international health authority regulations and guidelines. You will be responsible for preparing, submitting, and maintaining regulatory dossiers for drug approvals in various markets, managing post-approval changes, and providing expert guidance on regulatory requirements throughout the product lifecycle.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
Qualifications:
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
The ideal candidate possesses a deep understanding of pharmaceutical development, manufacturing, and quality systems, combined with extensive experience in navigating complex regulatory landscapes. You will lead a team of regulatory professionals, fostering collaboration and driving best practices in regulatory affairs. This position requires exceptional analytical skills, meticulous attention to detail, and the ability to anticipate and address regulatory challenges proactively. Your role will involve close interaction with internal stakeholders (R&D, clinical, manufacturing, quality) and external regulatory agencies, all managed within a remote-first operational framework.
Key Responsibilities:
- Develop and implement comprehensive global regulatory strategies for new and existing pharmaceutical products.
- Lead the preparation and submission of Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other marketing authorizations.
- Manage and maintain all regulatory filings, amendments, and renewals.
- Interpret and communicate complex regulatory requirements and guidelines to internal teams.
- Conduct regulatory intelligence activities to stay informed of evolving regulations and agency expectations.
- Oversee the regulatory review of labeling, promotional materials, and advertising.
- Liaise directly with health authorities (e.g., FDA, EMA, national agencies) on behalf of the company.
- Manage and mentor a team of regulatory affairs professionals, fostering their development and ensuring high performance.
- Contribute to the development and implementation of regulatory compliance programs.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Advanced degree (Master's, Pharm.D., Ph.D.) strongly preferred.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements (ICH, FDA, EMA, etc.).
- Experience managing and leading regulatory affairs teams.
- Excellent written and verbal communication skills, with strong negotiation abilities.
- Exceptional analytical and problem-solving skills, with meticulous attention to detail.
- Demonstrated ability to work effectively in a fully remote, collaborative environment, managing multiple projects and deadlines.
- Proficiency with regulatory information management systems is a plus.
This is a critical leadership role within a forward-thinking pharmaceutical company, offering the chance to shape regulatory strategies and contribute to bringing life-saving medicines to patients worldwide, all from a remote work setting.
This advertiser has chosen not to accept applicants from your region.
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Remote Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a detail-oriented and knowledgeable Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in a fully remote capacity. This vital role involves ensuring compliance with all relevant pharmaceutical regulations and guidelines throughout the product lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory documentation, liaising with regulatory agencies, and staying abreast of evolving regulatory requirements. The ideal candidate will possess a strong understanding of pharmaceutical drug development, regulatory processes, and international regulatory frameworks. Key responsibilities include managing regulatory submissions (e.g., INDs, NDAs, MAAs), reviewing product labeling for compliance, assessing changes to approved products, and providing regulatory guidance to internal teams. You will also be involved in regulatory strategy development and risk assessment. Experience with specific therapeutic areas or drug classes is advantageous. This is an exceptional opportunity to make a significant contribution to patient access to safe and effective medicines, working from a remote environment with a leading pharmaceutical organization. You must possess excellent analytical, organizational, and communication skills, with a keen eye for detail. The ability to interpret complex regulations and apply them effectively to specific situations is crucial. A bachelor's or master's degree in a relevant scientific field (e.g., Pharmacy, Chemistry, Biology) is required. This role demands a proactive approach, the ability to work independently, and strong collaboration skills to work effectively with cross-functional teams. The conceptual work location is **Mlolongo, Machakos, KE**, but the position is performed entirely remotely.
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client is seeking a highly knowledgeable and experienced Senior Pharmaceutical Regulatory Affairs Specialist to lead regulatory strategy and submissions for new drug products. This critical, fully remote position requires a deep understanding of global pharmaceutical regulations and a proven ability to navigate complex regulatory pathways. You will be responsible for developing and implementing regulatory strategies, preparing and submitting comprehensive regulatory dossiers to health authorities (e.g., FDA, EMA, CDSCO), and ensuring ongoing compliance throughout the product lifecycle. The ideal candidate will have extensive experience in the pharmaceutical industry, with a strong focus on regulatory affairs. Expertise in IND, NDA, ANDA, and MAA submissions, as well as post-approval lifecycle management, is essential. You must possess exceptional analytical, scientific writing, and communication skills, with the ability to interpret and apply complex regulatory guidelines. As a remote specialist, you will collaborate effectively with R&D, clinical affairs, quality assurance, and commercial teams, leveraging virtual collaboration tools to ensure seamless communication and alignment on regulatory objectives. We are looking for a proactive and detail-oriented professional who can anticipate regulatory challenges, provide strategic guidance, and drive successful product approvals in diverse international markets. This is an excellent opportunity to make a significant impact on global drug development and patient access from a flexible, remote work setting.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, ANDA, MAA) to health authorities worldwide.
- Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
- Manage and respond to queries from regulatory agencies during the review process.
- Oversee post-approval regulatory activities, including variations, renewals, and lifecycle management.
- Liaise with R&D, clinical, manufacturing, and quality assurance departments to gather necessary information for submissions.
- Provide regulatory guidance and support to project teams throughout the drug development process.
- Monitor changes in the regulatory landscape and assess their impact on company strategies.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
- Act as a key point of contact for regulatory authorities.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field; advanced degree (Master's or PhD) preferred.
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU).
- In-depth knowledge of regulatory requirements for small molecules, biologics, or generics.
- Experience with eCTD publishing and submission management systems.
- Excellent scientific writing, analytical, and critical thinking skills.
- Strong understanding of drug development processes and pharmaceutical manufacturing.
- Ability to manage multiple projects and meet tight deadlines in a remote environment.
- Excellent communication and interpersonal skills.
- Membership in relevant professional regulatory affairs associations is a plus.
This advertiser has chosen not to accept applicants from your region.
3
Lead Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 19 days ago
Job Viewed
Job Description
Our client, a leading name in the pharmaceutical industry, is actively seeking a highly experienced and detail-oriented Lead Pharmaceutical Regulatory Affairs Specialist. This is a fully remote role, allowing you to contribute from any location in Kenya. You will be instrumental in ensuring our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. This position demands a deep understanding of drug development, submission processes, and post-approval maintenance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to relevant health authorities.
- Monitor and interpret changes in pharmaceutical regulations and guidelines, providing proactive guidance to the organization.
- Liaise effectively with regulatory agencies, health authorities, and other stakeholders.
- Oversee the regulatory aspects of product lifecycle management, including variations, renewals, and amendments.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Provide regulatory input and support for product development, clinical trials, and marketing authorization applications.
- Manage regulatory documentation and databases, ensuring accuracy and completeness.
- Lead and mentor junior regulatory affairs professionals, fostering a collaborative and expert team environment.
- Conduct regulatory intelligence activities to stay abreast of evolving global regulatory landscapes.
Qualifications:
- Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, KEBS).
- Proven experience in preparing and submitting marketing authorization applications.
- Demonstrated experience managing regulatory submissions for various therapeutic areas.
- Excellent understanding of drug development processes and regulatory pathways.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working in a remote or hybrid team setting is highly desirable.
This advertiser has chosen not to accept applicants from your region.
4
Principal Remote Pharmaceutical Regulatory Affairs Specialist
Posted 16 days ago
Job Viewed
Job Description
Our client is actively seeking a highly accomplished and strategic Principal Remote Pharmaceutical Regulatory Affairs Specialist to navigate the complex landscape of pharmaceutical regulations worldwide. This is a fully remote position, offering the flexibility to influence global regulatory strategies from your home office. The successful candidate will be responsible for developing and executing comprehensive regulatory affairs strategies for the company's pharmaceutical products. This involves preparing, reviewing, and submitting regulatory documentation to health authorities in various regions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). You will stay abreast of evolving global regulatory requirements, guidelines, and trends, ensuring the company remains compliant and competitive. A significant aspect of this role involves providing expert regulatory guidance to cross-functional teams, including R&D, clinical affairs, manufacturing, and marketing, to ensure alignment with regulatory objectives. You will manage regulatory submissions throughout their lifecycle, responding to queries from health authorities and facilitating product approvals. The Principal Specialist will also play a key role in assessing the regulatory implications of product development, post-market changes, and lifecycle management activities. This position requires a deep understanding of pharmaceutical sciences, drug development processes, and international regulatory frameworks. Exceptional analytical, problem-solving, and project management skills are essential. Strong written and verbal communication abilities are critical for effective interaction with regulatory agencies and internal stakeholders in a remote setting. The ability to lead and influence teams, manage multiple projects simultaneously, and work independently with a high degree of accuracy is paramount. Experience in dossier preparation using common technical document (CTD) formats and proficiency with regulatory information management systems are highly desirable. This is an exceptional opportunity to shape the regulatory path of innovative medicines and contribute significantly to global health initiatives, working remotely near Thika, Kiambu, KE .
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5
Principal Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 19 days ago
Job Viewed
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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6
Remote Lead Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
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Job Description
Our client is seeking a highly accomplished and strategically-minded Lead Pharmaceutical Regulatory Affairs Specialist to guide their global regulatory strategy. This is a pivotal, fully remote leadership role demanding extensive experience in navigating complex pharmaceutical regulations across diverse international markets. You will be responsible for developing and executing regulatory submission plans, ensuring compliance with health authority requirements (e.g., FDA, EMA, local agencies), and managing all aspects of regulatory filings for new drug applications, variations, and post-approval changes. Your expertise will be crucial in interpreting regulatory guidelines, providing strategic advice to R&D and commercial teams, and ensuring that all product development and marketing activities align with current regulatory standards. Key responsibilities include leading regulatory team efforts, conducting regulatory intelligence gathering, preparing and reviewing regulatory documents, and serving as the primary liaison with regulatory agencies. The ideal candidate will possess a deep understanding of the pharmaceutical drug lifecycle, clinical development, and manufacturing processes, coupled with a proven track record in successful regulatory submissions and approvals. Exceptional analytical, communication, and negotiation skills are essential for effectively collaborating with internal stakeholders and external regulatory bodies. This role requires a proactive approach to identifying regulatory risks and opportunities, and the ability to develop innovative solutions to regulatory challenges. You will mentor and develop regulatory affairs professionals, fostering a culture of compliance and excellence. This is a unique opportunity to make a significant impact on global drug development and patient access to essential medicines, all within a flexible, fully remote work environment. We are seeking a seasoned regulatory expert with a visionary outlook and the ability to lead and inspire a remote team towards achieving critical regulatory milestones.
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7
Senior Pharmaceutical Regulatory Affairs Specialist (Remote)
Posted 19 days ago
Job Viewed
Job Description
Our client, a dynamic and innovative pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their fully remote global regulatory team. This critical position involves ensuring compliance with all national and international regulatory requirements for drug development, approval, and post-market surveillance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing expert guidance on regulatory strategies. The ideal candidate possesses a deep understanding of pharmaceutical regulations, excellent analytical skills, and a proven ability to navigate complex regulatory landscapes. This is an exceptional opportunity to contribute to bringing life-saving medicines to market while working remotely.
Key Responsibilities:
Key Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical product development and lifecycle management.
- Prepare, review, and submit regulatory documentation (e.g., INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
- Serve as the primary point of contact for regulatory agencies, responding to queries and managing submissions.
- Monitor and interpret evolving regulatory guidelines, legislation, and trends impacting the pharmaceutical industry.
- Assess regulatory requirements for new product development, clinical trials, and post-approval changes.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Ensure company compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP).
- Manage and maintain regulatory databases and documentation systems.
- Participate in regulatory audits and inspections.
- Contribute to the development and improvement of internal regulatory processes and SOPs.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. A Master's degree or Ph.D. is a plus.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers to major health authorities (e.g., FDA, EMA, MHRA).
- In-depth knowledge of pharmaceutical development processes, regulatory pathways, and global compliance requirements.
- Excellent understanding of ICH guidelines and other relevant international regulatory standards.
- Strong analytical, critical thinking, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Experience working effectively in a fully remote, collaborative team environment.
- Detail-oriented with strong organizational and project management abilities.
- Experience in specific therapeutic areas is an advantage.
This advertiser has chosen not to accept applicants from your region.
8
Senior Remote Pharmaceutical Regulatory Affairs Specialist
Posted 19 days ago
Job Viewed
Job Description
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Remote Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This fully remote role is crucial for navigating the complex regulatory landscape and ensuring compliance with global pharmaceutical standards. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and advising on regulatory strategies to support product development and market approval. The ideal candidate possesses a strong understanding of pharmaceutical regulations, meticulous attention to detail, and proven success in a remote work setting.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory dossiers for drug applications (e.g., IND, NDA, MAA) to relevant health authorities.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulatory guidelines.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, local health authorities) to facilitate the review process and respond to queries.
- Develop and implement global regulatory strategies to support product development and lifecycle management.
- Monitor and interpret changes in regulatory requirements and provide timely updates and recommendations to internal teams.
- Assess the regulatory impact of product changes, manufacturing processes, and promotional materials.
- Collaborate closely with R&D, Quality Assurance, Clinical Operations, and Commercial teams to ensure regulatory requirements are met.
- Maintain regulatory databases and ensure the accuracy and completeness of regulatory documentation.
- Provide regulatory training and guidance to internal stakeholders.
- Conduct regulatory intelligence activities to stay ahead of evolving requirements.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience working effectively in a remote capacity, managing regulatory submissions and communications from a distance.
- In-depth knowledge of global pharmaceutical regulatory requirements and submission processes (e.g., ICH guidelines).
- Proven experience in preparing and submitting various types of regulatory filings.
- Excellent written and verbal communication skills, with a strong ability to articulate complex regulatory information clearly.
- Strong analytical and problem-solving skills, with meticulous attention to detail.
- Proficiency in regulatory information management systems (RIMS) and document management systems.
- Ability to work independently, manage multiple priorities, and meet strict deadlines.
- Experience with a variety of therapeutic areas is a plus.
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