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Remote Pharmaceutical Regulatory Affairs Specialist
- plymouth, devon, PL5 2NN, United Kingdom
- Full time
- Remote
- £80,000 - £80,000 Per Annum
Job Description
About the Role
Our client is seeking a highly knowledgeable and experienced Remote Pharmaceutical Regulatory Affairs Specialist to join their global regulatory team. This critical role involves developing and implementing regulatory strategies to support the approval and lifecycle management of pharmaceutical products worldwide. You will be responsible for preparing and submitting regulatory dossiers, interacting with health authorities, and ensuring compliance with evolving global regulations. The ideal candidate is proactive, possesses a strong understanding of regulatory frameworks, and can effectively manage complex regulatory projects from a remote setting, ensuring timely market access for innovative medicines.
Key Responsibilities
- Develop and execute global regulatory strategies for new drug applications and product lifecycle management.
- Prepare, review, and submit regulatory documentation to health authorities, such as FDA, EMA , and other international agencies.
- Serve as a key point of contact for regulatory agency interactions and inspections.
- Interpret and provide guidance on complex regulatory requirements and guidelines.
- Monitor regulatory intelligence and industry trends to advise the organization on potential impacts and opportunities.
Requirements
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs .
- Proven experience with dossier preparation and submission (e.g., IND, NDA, MAA ).
- Thorough understanding of global regulatory requirements and guidelines (ICH, FDA, EMA).
- Excellent analytical, communication, and project management skills, suitable for remote work.
Benefits
- Highly competitive salary and bonus eligibility.
- Comprehensive benefits package including health, dental, and vision insurance.
- Home office equipment and internet reimbursement.
- Commitment to professional development and continuous learning.
- Opportunity to work on cutting-edge pharmaceutical products with a globally recognized company.