CMC - Regulatory Affairs Lead

CMC REGULATORY AFFAIRS LEAD | LEIDEN AREA | FULL-TIME 

Start: ASAP

Duration: until March 2026

Deadline to apply: 10 August 2025

Job Summary

This position plays a key role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. You will be responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC documents (e.g., CMC modules, IND/IMPD CMC documentation), for assigned products. Additionally, you will act as the subject matter expert (SME) for Regulatory CMC and works in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners)

• Serve as the CMC Regulatory Lead or Deputy for complex projects and strategic initiatives.
• Develop and author high-quality CMC documentation, including eCTD Quality Modules, IND/CTA/IBs, and briefing packages for health authority meetings.
• Provide expert guidance on global CMC regulatory strategy, collaborating closely with cross-functional teams including Pharmaceutical Technology, Manufacturing, Quality Assurance, and Business Partners.
• Interpret and apply global regulatory requirements (EMA, FDA, PMDA, ICH) to ensure compliance and consistency across submissions.
• Support new product planning and licensing due diligence with CMC regulatory expertise.
• Lead the preparation and review of global registration packages, ensuring clarity, scientific integrity, and regulatory compliance.
• Define and implement regulatory strategies for global and regional submissions, variations, and change control processes.
• Oversee submission timelines and quality standards, ensuring alignment with SOPs and regulatory expectations.
• Provide input on compendial matters (Ph.Eur., USP, JP) and contribute to monograph development.

Welkom bij Akkodis

We are Akkodis. We put the talents, skills and ambitions of our consultants first! Because you continuously offer challenging projects, you will develop quickly and you can realize your ambitions. Akkodis Life Sciences offers internal and external projects in the field of QA, QC, PV, RA, R&D and Supply Chain. Currently, more than 60 consultants work at the EMA, Astellas, GSK, Unilever, Corbion, MSD, Organon, Aspen and many more!

Kandidaat Profiel

Qualifications

• Minimum a bachelor’s degree in Chemistry, Pharmaceutics, Engineering, or a related scientific discipline.
• Advanced academic degree (Ph.D. or Pharm.D.) with 5+ years of relevant experience in product development within manufacturing or regulatory environments is preferred
• Minimum of 8 years of industry experience in pharmaceuticals, CROs, or academia, including at least 3 years in Regulatory Affairs or CMC regulatory roles with submission responsibilities.
• A background in regulatory experience with biologics, vaccines, cell therapies, or medical devices, complementing small molecule expertise would be a plus.
• Proven expertise in global CMC regulatory requirements across various dosage forms, particularly in complex and undefined technical frameworks.
• Hands-on experience in process development, analytical characterization, scale-up, and regulatory registration of drug substances or products (oral and/or parenteral).
• Demonstrated success in engaging with global health authorities regarding CMC submissions.

Are you interested in this challenge, or do you want to come in touch?

Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV and motivation letter.