Associate Director / Senior Regulatory Affairs CMC
On-siteBasel, Basel-City, Switzerland
Job Summary
Develop and execute global Regulatory Affairs CMC strategies across clinical development and registration programs, leading activities from clinical development through marketing application. Prepare, review, and drive high-quality Module 3 documentation for global submissions while supporting IND, IMPD, CTA, NDA, and MAA processes. Represent Regulatory Affairs CMC in multidisciplinary teams, providing strategic guidance on product development, technical changes, and lifecycle planning. Prepare and support interactions with regulatory agencies including FDA, EMA, and other Health Authorities. Evaluate regulatory risks and contribute to overall development strategy through close collaboration with CMC Development, Manufacturing, and external partners.
Required Qualifications
- Degree in Pharmacy, Chemistry or another Life Science discipline
- Several years of experience in Regulatory Affairs CMC within biotech or pharmaceutical development
- Proven experience supporting clinical development programs through late-stage development and registration
- Demonstrated experience with IND, IMPD, CTA, NDA and/or MAA submissions
- Strong expertise in CTD Module 3
- Experience interacting directly with regulatory agencies such as FDA and EMA
- Solid background in small molecule development
- Excellent communication skills with the ability to influence multidisciplinary project teams
- Fluent English
Desired Qualifications
- Experience supporting first marketing applications
- Experience in innovative biotech environments
- Experience working with outsourced manufacturing organizations and external development partners
- Scientific background combined with pragmatic regulatory thinking
- Previous exposure to global development programs from Phase I through registration
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.