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Director, Regulatory Cmc

12-15 years
Not Disclosed
10 March 4, 2025
Job Description
Job Type: Full Time Education: BA/BS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director, Regulatory CMC

Location: San Rafael, CA
Salary: $193K - $236K per year (estimated)
Employment Type: Full-time

About the Company:

BioMarin is a global biotechnology leader dedicated to developing innovative genetic medicines for patients with unmet medical needs. Since 1997, the company has leveraged expertise in genetics and molecular biology to create transformative therapies that improve human health.

Role Overview:

The Director, Regulatory CMC will play a key leadership role in the Worldwide Research & Development (WWRD) organization. This position will be responsible for developing global CMC regulatory strategies, managing regulatory submissions, and ensuring compliance with international regulatory requirements for both clinical and commercial products.

Key Responsibilities:

Regulatory Strategy & Compliance:

  • Serve as the Global Regulatory CMC Product Lead, developing and executing global CMC regulatory strategies.
  • Provide risk-based regulatory evaluations of manufacturing changes and offer strategic guidance.
  • Ensure compliance with global regulatory requirements across clinical trials, marketing applications, and post-approval variations.

Regulatory Submissions & Documentation:

  • Oversee the timely preparation and submission of regulatory filings, including clinical trial applications, marketing approvals, and post-approval maintenance.
  • Research and interpret global CMC regulations, providing regulatory insights to Quality, Manufacturing, and Process Development teams.
  • Lead interactions with global regulatory authorities to ensure rapid review and approval of submissions.

Cross-Functional Leadership:

  • Represent Regulatory Affairs CMC in cross-functional teams with Quality, Manufacturing, and other departments.
  • Develop strong relationships with internal and external stakeholders, ensuring alignment on regulatory strategies.
  • Mentor and guide junior-level Regulatory CMC professionals on strategic and technical matters.

Required Skills & Experience:

  • 12-15+ years of experience in Regulatory Affairs CMC within the pharmaceutical or biotech industry.
  • Proven experience with regulatory submissions and lifecycle management for biologics and small molecules in the US, EU, and global markets.
  • Expertise in assessing post-marketing changes and managing regulatory risks.
  • Strong leadership skills with a track record of leading cross-functional teams.
  • Excellent communication skills (both written and verbal) and the ability to collaborate in a matrixed environment.
  • Background in chemistry, molecular biology, or related fields preferred.

Preferred Qualifications:

  • Experience with combination products and global dossier management systems.
  • Strong knowledge of regulatory interactions, approvals, and variations.
  • Project management experience is a plus.
  • Ability to coach, train, and mentor team members.

Education:

  • BA/BS in life sciences, chemistry, or molecular biology required.
  • Advanced degree preferred.

Why Join BioMarin?

  • Be part of a company that is transforming genetic discoveries into life-changing medicines.
  • Work with a top-tier team of scientific experts in a collaborative, high-impact environment.
  • Competitive salary and comprehensive benefits package.