Principal Regulatory Affairs Consultant Expert
1 month ago
Lifelancer is seeking a highly qualified Principal Regulatory Affairs Consultant to join our team. As an Associate Director level professional, you will be responsible for providing expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule development.
This role offers a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities while working with clients to deliver exceptional consulting services.
Key Responsibilities:
- Serve as a Project Leader, overseeing project planning and execution, ensuring successful delivery of projects to meet client expectations.
- Maintain accurate project reporting, collaborate with cross-functional teams, and coordinate submission preparation with various departments.
- 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.
Experience and Skills Required:
- 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 such as registration files or variations.
The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval CMC activities. This is an excellent opportunity to work with a talented team and contribute to delivering exceptional consulting services to our clients.
We offer a competitive salary, £90,000 - £110,000 per annum, depending on experience, and a comprehensive benefits package. If you are a motivated and experienced professional looking for a new challenge, please apply now.
Please visit Lifelancer job page for more information and to submit your application.
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