Apsida Life Science
Regulatory Affairs Consultant
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Regulatory CMC Vaccine Consultant
Location: Remote – Western EU / UK
Contract: Long-Term Contract
Hours: Up to 150 hours per month
Start Date: Immediate
Company Overview:
Apsida Life Science is partnering with a leading global clinical research organization that provides end-to-end clinical development and regulatory consulting services to pharmaceutical, biotechnology, and medical device companies. With a strong global presence, the organization supports clients across the product lifecycle, delivering expertise in clinical research, regulatory affairs, pharmacovigilance, and market access to help bring innovative therapies to patients worldwide.
Key Responsibilities:
- Develop and implement regulatory CMC strategies for lifecycle management (LCM) of post-approval vaccine products.
- Support post-approval regulatory activities, including: Post-approval variations, Annual Strain Updates (ASU), Responses to post-approval commitments and CMC change-related activities.
- Provide regulatory CMC guidance for post-approval activities.
- Identify, assess, and communicate regulatory risks and potential impacts.
- Review CMC documents for submission readiness and ensure submissions conform to applicable Health Authority guidelines.
- Evaluate CMC change controls and provide regulatory assessment and recommendations.
- Contribute to regulatory briefing materials where required.
- Work closely with CMC, Regulatory Affairs, Quality, Manufacturing, and other cross functional teams.
- Support regulatory strategy and execution throughout the product lifecycle.
- Provide specific regulatory CMC support for the UK market.
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Requirements:
- Strong experience in Regulatory CMC, preferably within vaccines and/or biological products.
- Demonstrated experience supporting post-approval lifecycle management activities.
- Experience with post-approval variations and regulatory submissions.
- Experience with vaccines / Infectious Disease products.
- Experience supporting Annual Strain Updates (ASU) is highly desirable.
- Experience responding to post-approval commitments.
- Strong understanding of CMC regulatory requirements and Health Authority expectations.
- Experience evaluating CMC change controls from a regulatory perspective.
- Demonstrated ability to identify and communicate regulatory risks.
- Experience reviewing CMC documentation for submission readiness.
- Experience supporting the UK market is required.
- Strong knowledge of applicable global regulatory requirements and ICH guidelines.
- Excellent communication, problem-solving, and stakeholder-management skills.
- Ability to work independently and effectively within cross-functional teams.
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If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:
- Email: kgmphahlele@apsida.com
- Phone: +44 744 134 1041
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
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