Biogen

Associate Director, Regulatory CMC Small Molecule Lead

Biogen

full-time

Posted on:

Location Type: Hybrid

Location: Cambridge • Massachusetts • North Carolina • United States

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Salary

💰 $155,000 - $214,000 per year

Job Level

Senior

About the role

  • Oversee the management and coordination of regulatory CMC activities across assigned projects and products.
  • 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.
  • Lead regulatory assessments, ensuring compliance with evolving global CMC regulations, and maintaining strong relationships with global health authorities.

Requirements

  • 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.
Benefits
  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC activitiesRegCMC submissionsINDIMPDCTAsNDAsMAAsregulatory strategycomplianceCMC change management
Soft Skills
leadershipproject managementstrategic thinkingproblem-solvingrisk assessmentcommunicationmentoringcoachinginfluencing stakeholderscross-functional collaboration