Senior Regulatory Affairs Manager for Small Molecules
3 days ago
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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