Regulatory Affairs Specialist

1 month ago


Glasgow, Glasgow City, United Kingdom ProductLife Group Full time

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:



  1. Lead the preparation and submission of regulatory submissions, including marketing authorization applications, variations, and lifecycle management activities, ensuring alignment with EMA and MHRA requirements.
  2. 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.
  3. Develop and execute regulatory strategies tailored to the European and UK markets, ensuring timely product registration, approval, and post-market compliance.
  4. Writing sections of the Module 3 of dossiers and Quality Overall Summaries
  5. Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. Coordination and review technical documentation.
  6. Collaborate closely with internal stakeholders, including Pharmacovigilance and Quality teams to align regulatory objectives and support business goals.
  7. Collaborate closely with client teams and internal consultants to deliver comprehensive regulatory solutions that meet business objectives and regulatory standards.
  8. Represent clients in interactions with European and UK regulatory agencies, including participation in regulatory meetings, responses to inquiries, and management of regulatory submissions.

Requirements:



  1. Graduate in a Science based subject. Minimum of 5 years experience in Regulatory affairs.
  2. In-depth knowledge of European and UK regulatory requirements, procedures, and guidelines.
  3. Excellent verbal and written communication skills with high level of attention to detail and accuracy of work.
  4. Strong organisation skills and ability to cope with large volume of work across different areas of the company with changing deadlines.
  5. Strategic mindset with a focus on delivering value-added regulatory solutions and fostering long-term client relationships.
  6. 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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