Regulatory Affairs Specialist

4 days ago


Leeds, Leeds, United Kingdom Lifelancer Full time

Lifelancer, a pioneering talent-hiring platform in Life Sciences, Pharma and IT, is seeking an accomplished Regulatory Affairs Specialist to join our team. This role offers a unique opportunity to leverage your expertise in small molecule processes and regulatory affairs within the pharmaceutical industry.

About the Role

The ideal candidate will possess strong knowledge of Chemistry, Manufacturing, and Controls (CMC) and post-approval regulatory requirements. As a key member of our team, you will utilize your exceptional project leadership and management skills to deliver high-quality consulting services to our clients.

Key Responsibilities:
  • Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control, and quality assurance.
  • Write and review submission content to ensure alignment with regulatory requirements.

This position can be home or office based in various European locations. You will have the opportunity to collaborate within a team environment, prioritize workloads, and achieve project scope and objectives.

Experience and Skills Required:

To succeed in this role, you must have:

  • A university-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents.
  • Knowledge of small molecule processes.
  • Proficient account planning and support abilities.

We offer a competitive salary package, estimated at £80,000 - 100,000 per annum, depending on experience. This includes a comprehensive benefits package and opportunities for professional growth and development.



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