Associate Director

Description:

As Associate Director, Regulatory CMC Small Molecule Lead, you will play a pivotal role in shaping and executing the global Regulatory Chemistry, Manufacturing and Controls (RegCMC) strategy for Biogen’s small molecule portfolio. You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management.

This position requires a strategic thinker and strong communicator with deep regulatory CMC expertise who thrives in a global, matrixed environment.

What You’ll Do

The Associate Director, RegCMC Small Molecule Lead oversees the management and coordination of regulatory CMC activities across assigned projects and products. Primary duties include:
 

• Lead cross-functional teams responsible for global RegCMC submissions (IND/IMPD/CTAs, NDAs/MAAs) and responses to Health Authority questions.
• Define and implement global RegCMC regulatory strategy to support development and commercial objectives.
• Communicate RegCMC strategies, risks, and plans effectively to leadership and project teams.
• Ensure regulatory strategies align with business goals and meet Health Authority requirements.
• Monitor and influence global RegCMC environment changes; contribute to internal process and policy improvements.
• Mentor and coach team members, supporting skill development within the RegCMC organization.
   

This position is also responsible for leading regulatory assessments, ensuring compliance with evolving global CMC regulations, and maintaining strong relationships with global health authorities.

Who You Are

You are an experienced regulatory professional with deep technical understanding of CMC development for small molecule products. You bring a strategic mindset, a collaborative spirit, and the ability to lead global cross-functional teams to achieve regulatory success.

Required Skills
 

• Bachelor’s degree in Life Sciences, Engineering, Biotechnology, or a relevant Pharmaceutical Science; graduate degree preferred.
• Minimum 10+ years of relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, including at least 7+ years in RegCMC.
• Proven success authoring and delivering CMC submissions for development and marketed products (chemical, biological, or oligonucleotide entities).
• Broad experience with registration procedures in ICH regions and direct communication with health authorities.
• In-depth knowledge of global regulations, ICH/GMP requirements, and CMC change management systems.
• Strong leadership and project management skills with ability to work cross-functionally and influence stakeholders.
• Demonstrated strategic thinking, problem-solving, and risk assessment abilities.
• Excellent written and verbal communication skills, including experience working across global time zones and cultures.