2 Senior Pharmaceutical Regulatory Affairs Manager Remote jobs in whatjobs
Senior Pharmaceutical Regulatory Affairs Manager (Remote)
Posted 4 days ago
Job Viewed
Job Description
Our client, a globally recognized pharmaceutical company dedicated to advancing healthcare, is seeking a highly accomplished Senior Pharmaceutical Regulatory Affairs Manager for a fully remote position. This essential role will ensure our client's products meet all required regulatory standards and facilitate smooth market entry and compliance worldwide. You will be responsible for developing and executing regulatory strategies, preparing and submitting regulatory dossiers, and managing interactions with health authorities. Key responsibilities include staying abreast of evolving regulatory landscapes, assessing the impact of new regulations on existing products, and providing expert guidance on compliance matters. The successful candidate will lead the review of labeling, advertising, and promotional materials to ensure regulatory adherence. Experience in negotiating with regulatory agencies and successfully navigating complex approval processes is vital. You will also be involved in lifecycle management of approved products, including post-market surveillance and compliance activities. A minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements (e.g., FDA, EMA, WHO), is required. A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field is essential. Excellent analytical, problem-solving, and strategic thinking skills are paramount. Outstanding written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences, are necessary. This remote role, conceptually linked to **Machakos, Machakos, KE**, offers the flexibility to work from anywhere in Kenya and contributes significantly to bringing life-saving medicines to patients globally.
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Senior Pharmaceutical Regulatory Affairs Manager (Remote)
Posted 1 day ago
Job Viewed
Job Description
Our client is seeking a highly accomplished Senior Pharmaceutical Regulatory Affairs Manager to lead their regulatory compliance efforts. This is a critical role that requires deep expertise in global pharmaceutical regulations and a strategic approach to ensuring market access for our client's innovative products. You will be responsible for developing and implementing regulatory strategies, preparing and submitting regulatory dossiers to health authorities worldwide (e.g., FDA, EMA, national agencies), and managing post-approval regulatory activities. Your responsibilities will include interpreting complex regulatory guidelines, assessing the regulatory impact of product changes, and ensuring adherence to all applicable laws and regulations. The ideal candidate will have a strong track record of successful regulatory submissions and approvals, excellent analytical and communication skills, and the ability to lead and mentor a team. Experience in pharmacovigilance and quality assurance is highly beneficial. You will liaunt with internal departments (R&D, Manufacturing, Marketing) and external regulatory bodies to ensure alignment and facilitate timely approvals. This role requires a proactive individual who can anticipate regulatory trends and challenges and develop strategies to address them. The successful candidate will play a key role in the lifecycle management of pharmaceutical products, from early development through to post-market surveillance. Strong negotiation skills and the ability to navigate complex regulatory landscapes are essential. You will be responsible for the development and implementation of regulatory policies and procedures.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and execute global regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
- Manage post-approval regulatory activities, including lifecycle management and variations.
- Interpret regulatory requirements and provide guidance to internal teams.
- Assess the regulatory impact of product changes and manufacturing processes.
- Liaise with health authorities to facilitate discussions and address queries.
- Monitor and analyze changes in the global regulatory landscape.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines.
- Lead and mentor the regulatory affairs team.
- Oversee regulatory aspects of product labeling and advertising.
Qualifications:
- Master's degree or PhD in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 10 years of experience in pharmaceutical regulatory affairs.
- Extensive knowledge of global regulatory requirements (FDA, EMA, etc.) and submission processes.
- Proven track record of successful regulatory submissions and approvals.
- Experience with various dosage forms and therapeutic areas.
- Excellent analytical, strategic thinking, and problem-solving skills.
- Outstanding written and verbal communication skills, with strong presentation abilities.
- Demonstrated leadership and team management experience.
- Ability to work under pressure and meet strict deadlines.
This advertiser has chosen not to accept applicants from your region.
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