Associate Director Regulatory Affairs CMC
Gloor&Lang
Innovative Biopharmaceutical Company | Northwestern Switzerland
Shape the Regulatory Future of Innovative Small Molecule TherapiesOur client is an innovative and fast-growing biopharmaceutical company developing breakthrough therapies for patients with high unmet medical needs. As the development portfolio advances towards late-stage clinical development and registration, we are looking for an experienced Regulatory Affairs CMC professional to strengthen the global Regulatory organization.This is an excellent opportunity for a senior expert who enjoys working in a dynamic biotech environment and wants to play a key role in bringing innovative medicines to market.Your ResponsibilitiesLead the global Regulatory Affairs CMC strategy for development and registration programs.
Drive the preparation and review of high-quality CMC documentation (Module 3) for global regulatory submissions.
Support and coordinate IND, IMPD, NDA and MAA submissions throughout the product lifecycle.
Act as the Regulatory CMC expert in cross-functional project teams, collaborating closely with CMC Development, Analytical Development, Manufacturing, Quality and external partners.
Provide strategic regulatory guidance for CMC changes, lifecycle management and health authority interactions.
Contribute to regulatory risk assessments and the overall development strategy.
Build strong relationships with internal stakeholders and external regulatory partners.
Support the further development of Regulatory Affairs CMC capabilities within the organization.
Your ProfileDegree in Pharmacy, Chemistry, Pharmaceutical Sciences or a related Life Science discipline.
Extensive experience in Regulatory Affairs CMC within the pharmaceutical or biotechnology industry.
Strong expertise in small molecule development.
Proven experience preparing and supporting NDA, MAA, IND and/or IMPD submissions, including substantial ownership of CMC Module 3.
Solid understanding of global regulatory requirements (FDA, EMA and ICH guidelines).
Experience working in multidisciplinary development teams.
Excellent communication and stakeholder management skills.
Fluent English.
Nice to HaveExperience with anti-infectives or other highly specialized therapeutic areas.
Experience in late-stage clinical development and first marketing authorization applications.
Previous experience in an innovative biotech environment.
What You Can ExpectA highly visible role with strategic impact.
Close collaboration with experienced scientific and regulatory leaders.
A dynamic biotech environment where decisions are made quickly and innovation is encouraged.
The opportunity to contribute directly to bringing innovative therapies to patients worldwide.
Attractive employment conditions and long-term career development.
Interested? We are looking forward to get in touch with you.
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