Regulatory Affairs Specialist
1 month ago
Job Title: Senior Regulatory Affairs Executive
About the Role: We are seeking a highly experienced Senior Regulatory Affairs Executive to join our team at ProductLife Group.
Key Responsibilities:
- Lead the preparation and submission of regulatory submissions, including marketing authorization applications, variations, and lifecycle management activities, ensuring alignment with EMA and MHRA requirements.
- Preparation of regulatory submissions for medicinal products, which may include, but are not limited to, new licence applications, variations, PIQ submissions, responses to questions and renewals.
- Develop and execute regulatory strategies tailored to the European and UK markets, ensuring timely product registration, approval, and post-market compliance.
- Writing sections of the Module 3 of dossiers and Quality Overall Summaries
- Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. Coordination and review technical documentation.
- Collaborate closely with internal stakeholders, including Pharmacovigilance and Quality teams to align regulatory objectives and support business goals.
- Collaborate closely with client teams and internal consultants to deliver comprehensive regulatory solutions that meet business objectives and regulatory standards.
- Represent clients in interactions with European and UK regulatory agencies, including participation in regulatory meetings, responses to inquiries, and management of regulatory submissions.
Requirements:
- Graduate in a Science based subject. Minimum of 5 years experience in Regulatory affairs.
- In-depth knowledge of European and UK regulatory requirements, procedures, and guidelines.
- Excellent verbal and written communication skills with high level of attention to detail and accuracy of work.
- Strong organisation skills and ability to cope with large volume of work across different areas of the company with changing deadlines.
- Strategic mindset with a focus on delivering value-added regulatory solutions and fostering long-term client relationships.
- Ability to work well both alone and as part of a team.
Benefits:
- Competitive salary commensurate with experience.
- Annual performance related bonus.
- Contributory Pension.
- 25 days annual leave.
- East Midlands Office based but flexible working arrangements available.
ProductLife Group is a well-established Consultancy in the pharmaceutical space. We are committed to delivering outstanding service to our clients and fostering long-term relationships. If you are a motivated and experienced Regulatory Affairs Executive looking for a new challenge, please apply for this exciting opportunity.
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