Associate Director Regulatory Affairs CMC

Innovative Biopharmaceutical Company | Northwestern Switzerland

Shape the Regulatory Future of Innovative Small Molecule Therapies

Our 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.

• Lead 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.

• Degree 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.

• Experience 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.

• A 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.