Regulatory Affairs CMC Specialist
Remote working, EST/ European Time Zone
We are seeking an experienced Regulatory Affairs professional with strong CMC expertise to support global regulatory activities across a diverse portfolio. This role is ideal for someone with advanced knowledge of regulatory requirements and experience across multiple modalities, particularly peptides and proteins.
You will play a key role in shaping regulatory strategy, leading submissions, and engaging with global health authorities to ensure successful product development and lifecycle management.
Key Responsibilities
Regulatory Strategy & Submissions
- Lead submission planning by applying regulatory intelligence and developing effective global regulatory strategies
- Prepare, compile, and maintain high-quality regulatory dossiers
- Manage and execute submissions to health authorities worldwide, including:
- MAA, NDA, BLA
- CTA/IND
- Device Files, CE marking, NBOp
- Site Master Files
- Renewals, post-approval changes, and commitments
- Respond to health authority questions and ensure timely follow-up
Health Authority Interactions
- Plan and lead regulatory interactions with global health authorities
- Prepare meeting requests, briefing packages, and coordinate rehearsals
- Document and communicate outcomes from formal meetings
- Support affiliates in preparing for regulatory interactions
Cross-functional Collaboration
- Act as a key member of the RA matrix team
- Represent Regulatory Affairs to ensure alignment of strategy and planning
- Facilitate effective information flow across cross-functional teams
- Collaborate with affiliates and internal stakeholders globally
RA Process Lead
- Drive continuous improvement in regulatory processes, documentation, and strategy development
RA Due Diligence Expert
- Lead regulatory due diligence activities, including:
- Assessment of CMC data packages and development plans
- Identification of critical regulatory risks
- Evaluation of product positioning and competitive landscape
CMC Product Lead
- Own the overall RA CMC/device regulatory strategy (including DDC products)
- Align with global and affiliate teams to ensure timely execution
- Communicate business-critical decisions, risks, and resource constraints
Essential skills:
- Around 10-15 years of experience in Regulatory Affairs
- Advanced understanding of regulatory affairs, with strong CMC expertise
- Experience with multiple modalities (peptides and proteins highly desirable)
- In-depth knowledge of global regulatory requirements (USA, EU, Japan, China)
- Experience across all stages of drug development, including lifecycle management (LCM)
- Proven track record of managing global regulatory submissions and health authority interactions
- Experience authoring Module 3 CTD documentation
…