Associate Director/Senior Manager, CMC Regulatory
Help shape the regulatory strategy behind innovative pharmaceutical products across their development and post-approval lifecycles. In this influential role, you’ll provide scientific CMC expertise, work with multidisciplinary teams across regions, and help advance products towards submission, approval and continued regulatory compliance.
Overview
This is an opportunity to join a small, collaborative CMC Regulatory team supporting multiple products across the EMEA region, while working closely with colleagues in Japan and the US. The role covers approximately 25% development activity and 75% post-approval work, with a primary focus on small-molecule products.
Key Responsibilities
- Establish and implement CMC regulatory strategies for development projects and approved products.
- Lead the preparation and review of regulatory submission dossiers, including CTD Module 3/source documents and Quality Overall Summaries.
- Prepare regulatory communications, briefing documents and responses to Health Authority questions.
- Provide CMC Regulatory input into submissions, clinical development plans, variations and renewal activities.
- Represent CMC expertise at internal and Health Authority meetings.
- Identify regulatory risks and proactively develop practical solutions.
- Assess proposed manufacturing and quality changes and determine the appropriate regulatory measures.
- Collaborate with CMC, manufacturing, Quality Assurance, clinical, regulatory and commercial stakeholders across regions.
- Support lifecycle management, post-approval changes and delivery of Health Authority commitments.
Must-Have
- At least five years’ hands-on CMC lifecycle management experience within the EMEA region.
- Experience supporting both development and post-approval activities for small-molecule products.
- Experience preparing regulatory submissions and engaging with regulatory agencies on CMC or Quality matters.
- Strong knowledge of CMC Regulatory Affairs, Quality Assurance, applicable regulations and Health Authority requirements.
- Experience managing multiple projects and working effectively across multidisciplinary teams.
- Bachelor’s degree in Chemistry, Biological Science, Pharmacy or another scientific or technical discipline.
Nice-to-Have
- Experience with biologics.
- Experience preparing IMPDs or CTAs.
- Laboratory experience.
- Advanced degree such as an MSc or PhD.
Bring your CMC Regulatory expertise to a role where your work can directly support product development, approval and ongoing patient access–
Associate Director/Senior Manager, CMC Regulatory employer: Planet Pharma Group
Planet Pharma Group is an exceptional employer that fosters a dynamic and inclusive work culture, where innovation in healthcare technology thrives. Employees benefit from flexible hybrid working arrangements, comprehensive professional development opportunities, and a commitment to enhancing patient care, making it a rewarding place to grow your career while making a meaningful impact in the industry.
