Senior Regulatory Affairs Manager for Small Molecules

3 days ago


Leeds, Leeds, United Kingdom Lifelancer Full time

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Senior Regulatory Affairs Manager to join their team. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval Chemistry, Manufacturing, and Controls (CMC) activities.

This role offers an exciting opportunity to showcase technical skills, specialist knowledge, and mentorship abilities while working with clients across various European locations.

**Key Responsibilities:

  • Act as a Project Leader, providing overall project leadership and ensuring successful planning and set-up.
  • Develop and implement submission strategies and plans for post-approval CMC activities.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Collaborate within a team environment to deliver project requirements.

**Required Skills and Qualifications:

  • 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 sections of regulatory documents.

The estimated salary range for this position is between $100,000 and $150,000 per annum, depending on location and experience.

Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. If you are interested in this role, please visit our website for more information and apply directly.



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