Associate Director Regulatory Affairs CMC

gloor & lang ag seeks an Associate Director of Regulatory Affairs CMC in Basel to lead global CMC strategy and submissions for late-stage biopharmaceutical programs.

This position is designed to bolster the global Regulatory Affairs team at an innovative biopharmaceutical firm focused on breakthrough therapies. The role involves steering the CMC strategy for development and registration, ensuring high-quality documentation for global submissions, and acting as the primary regulatory expert within cross-functional teams to support the advancement of the portfolio toward late-stage clinical trials and market authorization.

Responsibilities

• Define and execute the global CMC regulatory strategy for development and registration programs.
• Prepare and review CMC documentation, specifically Module 3, for international regulatory filings.
• Coordinate and support the submission process for IND, IMPD, NDA, and MAA applications across the product lifecycle.
• Serve as the CMC regulatory subject matter expert in cross-functional projects, working closely with development, manufacturing, quality, and external partners.
• Provide strategic advice on CMC changes, lifecycle management, and interactions with health authorities.
• Participate in regulatory risk assessments and contribute to the overall development strategy.
• Establish and maintain strong relationships with internal stakeholders and external regulatory bodies.
• Help build and enhance CMC regulatory capabilities within the organization.

Requirements

• University degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related Life Science field.
• Significant experience in Regulatory Affairs CMC within the pharmaceutical or biotechnology sector.
• Deep expertise in small molecule development.
• Proven track record in preparing and supporting NDA, MAA, IND, and/or IMPD submissions, with substantial responsibility for CMC Module 3.
• Strong knowledge of global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Experience collaborating in multidisciplinary development teams.
• Excellent communication and stakeholder management abilities.
• Fluent proficiency in English.

Nice to have

• Background in anti-infectives or other highly specialized therapeutic areas.
• Experience in late-stage clinical development and first marketing authorization applications.
• Prior work in an innovative biotech environment.

What the company offers

• A high-visibility position with strategic impact on the company's goals.
• Close collaboration with experienced scientific and regulatory leaders.
• A dynamic biotech environment that encourages quick decision-making and innovation.
• The chance to directly contribute to bringing innovative therapies to patients globally.
• Attractive employment conditions and opportunities for long-term career development.

About the company

gloor & lang ag is an innovative and fast-growing biopharmaceutical company dedicated to developing breakthrough therapies for patients with high unmet medical needs. The organization operates in a dynamic environment where decisions are made quickly and innovation is encouraged, with a portfolio advancing toward late-stage clinical development and registration.

• Innovative and fast-growing company culture.
• Dynamic environment with quick decision-making processes.
• Encouragement of innovation and strategic impact.