5 Senior Regulatory Affairs Specialist Pharmaceuticals jobs in whatjobs
Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 20 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company dedicated to improving global health outcomes, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their remote team. This critical role involves ensuring compliance with all relevant national and international regulations for our client's pharmaceutical products.
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
Qualifications:
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
The successful candidate will be responsible for managing the regulatory submission process, maintaining product registrations, and providing expert guidance on regulatory requirements. This position demands meticulous attention to detail, a deep understanding of pharmaceutical regulations, and excellent communication skills to liaise with health authorities and internal departments.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
- Manage and maintain product registrations and licenses, ensuring timely renewals and compliance with post-approval commitments.
- Interpret and advise on complex regulatory requirements, guidelines, and changes affecting pharmaceutical products.
- Develop regulatory strategies for new product development and lifecycle management.
- Act as the primary point of contact for regulatory health authorities, addressing inquiries and facilitating communication.
- Review and approve labeling, promotional materials, and advertising for compliance with regulations.
- Conduct regulatory intelligence activities to monitor evolving legislation and provide proactive guidance.
- Collaborate with R&D, Quality Assurance, Clinical Affairs, and Commercial departments to ensure regulatory compliance throughout the product lifecycle.
- Identify and assess regulatory risks and develop mitigation strategies.
- Contribute to the development and implementation of departmental Standard Operating Procedures (SOPs).
- Mentor junior regulatory affairs personnel.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. Advanced degree (Master's or PharmD) is preferred.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals across multiple global markets.
- In-depth knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA, WHO).
- Experience with electronic submission portals and regulatory information management systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Strong project management abilities and the capacity to manage multiple complex projects simultaneously.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
- Ability to work independently and collaboratively in a fast-paced, remote environment.
- High ethical standards and commitment to compliance.
This is an exceptional opportunity for a dedicated regulatory affairs professional to advance their career with a leading pharmaceutical innovator, enjoying the flexibility of a fully remote role. Contribute to bringing life-changing medicines to patients worldwide.
Although the role is remote, the company has a significant presence and focus in the region of Naivasha, Nakuru, KE .
This advertiser has chosen not to accept applicants from your region.
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Senior Regulatory Affairs Specialist, Pharmaceuticals
Posted 20 days ago
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking a highly qualified Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This role is critical for ensuring that our client's pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. You will be responsible for preparing, submitting, and managing regulatory documentation for new drug applications, variations, and renewals, as well as interacting with regulatory agencies. The ideal candidate possesses a deep understanding of pharmaceutical regulations, a meticulous approach to documentation, and excellent communication skills.
Key Responsibilities:
Qualifications:
This is a key role for ensuring our client's market access and compliance. If you are a dedicated regulatory affairs professional seeking a challenging and rewarding remote opportunity, we encourage you to apply.
Key Responsibilities:
- Prepare and submit high-quality regulatory submissions (e.g., CTD, NDA, ANDA, variations, renewals) to health authorities in target markets.
- Maintain a thorough understanding of current and evolving regulatory requirements in relevant jurisdictions.
- Manage the regulatory lifecycle of assigned products, ensuring ongoing compliance.
- Liaise with regulatory agencies during the review process, responding to queries and providing necessary information.
- Develop and implement regulatory strategies to support product development and commercialization goals.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Conduct regulatory intelligence activities to identify new opportunities and potential risks.
- Collaborate with internal teams (R&D, Clinical, Quality, Manufacturing) to gather information and ensure alignment on regulatory strategies.
- Assess the regulatory impact of manufacturing changes, quality deviations, and clinical trial results.
- Maintain regulatory databases and ensure accurate record-keeping.
- Provide regulatory guidance and training to internal stakeholders.
- Participate in due diligence activities for potential acquisitions or partnerships.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience in preparing and submitting diverse regulatory dossiers to various health authorities.
- In-depth knowledge of global pharmaceutical regulatory guidelines (e.g., ICH, FDA, EMA, WHO).
- Experience with both prescription drugs and OTC products is desirable.
- Strong understanding of drug development, manufacturing processes, and quality assurance.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Exceptional attention to detail and organizational skills.
- Ability to work independently, manage multiple projects, and meet strict deadlines in a remote environment.
- Proficiency in regulatory information management systems and standard office software.
- Experience in specific therapeutic areas is a plus.
This is a key role for ensuring our client's market access and compliance. If you are a dedicated regulatory affairs professional seeking a challenging and rewarding remote opportunity, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
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Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 20 days ago
Job Viewed
Job Description
Our client, a prominent pharmaceutical company committed to advancing global health, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their fully remote team. This critical role will focus on ensuring compliance with regulatory requirements for pharmaceutical product development, registration, and lifecycle management, all while working from your home base in **Mlolongo, Machakos, KE**. The ideal candidate will possess an in-depth understanding of global regulatory landscapes, including FDA, EMA, and other key health authority requirements. You will be responsible for preparing, submitting, and maintaining regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and variations. Your role will involve advising project teams on regulatory strategies, assessing the regulatory impact of proposed changes, and ensuring adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP). We are looking for a candidate with a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field, and a minimum of 6 years of progressive experience in pharmaceutical regulatory affairs. A Master's degree or Pharm.D. is a significant advantage. Proven experience in successfully navigating complex regulatory submissions and maintaining product registrations is essential. Exceptional attention to detail, strong analytical and communication skills, and the ability to manage multiple complex projects simultaneously in a remote setting are paramount. If you are a dedicated regulatory affairs professional looking for a challenging and impactful remote opportunity to contribute to bringing life-saving medications to market, we encourage you to apply.
Responsibilities:
Responsibilities:
- Develop and execute global regulatory strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., IND, NDA, MAA) to health authorities.
- Manage post-approval regulatory activities, including variations and lifecycle management.
- Liaise with health authorities to facilitate the regulatory review process.
- Advise R&D, clinical, and manufacturing teams on regulatory requirements and strategy.
- Assess the regulatory impact of product changes and deviations.
- Ensure compliance with relevant pharmaceutical regulations and guidelines (GMP, GCP, GVP).
- Monitor regulatory intelligence and advise on evolving global requirements.
- Maintain regulatory documentation and databases.
- Contribute to regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science. Master's degree or Pharm.D. is preferred.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH, etc.).
- Proven experience in preparing and submitting various regulatory filings.
- Strong understanding of pharmaceutical product development and lifecycle management.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills.
- Ability to manage multiple projects effectively and meet tight deadlines in a remote environment.
- Detail-oriented with a strong commitment to compliance and quality.
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 20 days ago
Job Viewed
Job Description
Our client is seeking a highly qualified and experienced Senior Regulatory Affairs Specialist to join their fully remote pharmaceutical team. This role is critical for ensuring that our client's pharmaceutical products comply with all relevant national and international regulations. You will be responsible for preparing and submitting regulatory filings, maintaining regulatory documentation, and staying current with evolving regulatory landscapes. The ideal candidate will have a deep understanding of the drug development and approval process, with a strong focus on regulatory strategy. You will work closely with R&D, quality assurance, and commercial teams to provide expert guidance on regulatory requirements throughout the product lifecycle. This position requires meticulous attention to detail, excellent analytical skills, and the ability to manage multiple complex projects simultaneously. As a remote position, you must possess excellent communication skills and the ability to collaborate effectively with a dispersed team. We are looking for a proactive individual who can anticipate regulatory challenges and develop effective solutions. This is an excellent opportunity to contribute to the development and commercialization of innovative medicines while working in a flexible, remote environment. The successful candidate will play a key role in bringing life-saving and life-enhancing therapies to market. Your expertise will be vital in navigating the intricacies of pharmaceutical regulations. The role supports our client's operations, with a key focus on the region around Ongata Rongai, Kajiado, KE . Join a dedicated team committed to excellence in pharmaceutical regulation from the convenience of your home office.Responsibilities:
- Prepare and submit regulatory dossiers for new drug applications (NDAs) and variations.
- Ensure compliance with all applicable local and international pharmaceutical regulations.
- Maintain up-to-date knowledge of regulatory guidelines and agency requirements.
- Liaise with regulatory authorities on submissions and inquiries.
- Develop and implement regulatory strategies for product development and commercialization.
- Review and approve labeling, promotional materials, and advertising for regulatory compliance.
- Provide regulatory guidance to R&D, clinical, quality, and marketing teams.
- Manage post-approval regulatory activities, including annual reports and supplements.
- Conduct regulatory intelligence activities and assess impact on current and future products.
- Oversee the maintenance of regulatory documentation and databases.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory filings (e.g., NDAs, CTAs).
- In-depth knowledge of pharmaceutical regulatory requirements and guidelines (e.g., FDA, EMA, KEBS).
- Excellent analytical, problem-solving, and project management skills.
- Strong written and verbal communication abilities.
- Ability to work independently and manage projects effectively in a remote setting.
- Experience with specific therapeutic areas is a plus.
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist - Pharmaceuticals
Posted 17 days ago
Job Viewed
Job Description
Our client is a rapidly growing pharmaceutical company seeking a highly competent and detail-oriented Senior Regulatory Affairs Specialist to join their international team. This is a fully remote position, offering an exceptional opportunity to contribute to the global drug development and approval process from your home office. You will be responsible for developing and executing regulatory strategies for product registration and lifecycle management in various target markets. This includes preparing and submitting regulatory dossiers (e.g., CTD, IND, NDA), liaising with health authorities, and ensuring compliance with global regulatory requirements and guidelines. Your expertise will be crucial in navigating complex regulatory landscapes and facilitating the timely market access of our innovative pharmaceutical products. The ideal candidate will possess a strong understanding of pharmaceutical product development, manufacturing, and quality assurance processes.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and registration.
- Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serve as the primary point of contact for regulatory agencies, managing communications and responses.
- Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, manufacturing, and marketing.
- Interpret and apply relevant regulatory guidelines and legislation.
- Manage the regulatory aspects of product lifecycle management, including post-approval changes and renewals.
- Conduct regulatory intelligence activities to stay abreast of evolving requirements and competitor activities.
- Review labeling, promotional materials, and advertising for regulatory compliance.
- Contribute to the development of regulatory policies and procedures.
- Ensure adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) where applicable.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- A minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.
- Proven experience in preparing and submitting successful regulatory dossiers to major health authorities (e.g., FDA, EMA, PMDA).
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., ICH).
- Strong understanding of drug development processes, clinical trials, and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with a strong ability to write clear and concise regulatory documents.
- Proficiency in regulatory information management systems and common office software.
- Ability to work independently, manage multiple projects simultaneously, and meet demanding deadlines in a remote setting.
- Experience with biosimilars or biologics is a plus.
This advertiser has chosen not to accept applicants from your region.
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