Position Summary
We are a clinical-stage biotechnology company advancing innovative therapeutics to address areas of significant unmet medical need. Our team combines scientific rigor with a collaborative, execution-focused culture, and we are building a best-in-class regulatory and CMC foundation to support rapid and sustainable development.
We are seeking an experienced CMC Regulatory Lead to provide strategic and operational leadership for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities. This individual will serve as the primary owner of CMC regulatory strategy across development programs, ensuring alignment with global regulatory requirements and supporting successful progression from early development through commercialization.
The CMC Regulatory Lead will work closely with Technical Operations, Quality, Clinical Development, and external partners to drive high-quality regulatory submissions and effective health authority interactions. This is a hands‑on leadership role well‑suited for candidates who thrive in a fast‑paced, on‑site biotech environment.
Key Responsibilities
CMC Regulatory Strategy & Leadership
- Develop and execute global CMC regulatory strategies to support IND, CTA, NDA/BLA, and lifecycle submissions.
- Serve as the primary regulatory CMC point of contact for health authority interactions (e.g., FDA, EMA).
- Provide strategic guidance on CMC development plans to ensure regulatory compliance and approval readiness.
Regulatory Submissions & Documentation
- Lead preparation, review, and submission of CMC sections for regulatory filings, including INDs, amendments, annual reports, and marketing applications.
- Ensure consistency, quality, and scientific accuracy of CMC regulatory documentation.
- Oversee responses to health authority questions, information requests, and deficiency letters related to CMC.
Cross-Functional Collaboration
- Partner closely with CMC, Technical Operations, Quality, Clinical Operations, and Regulatory Affairs colleagues to align development, manufacturing, and regulatory strategies.
- Support selection, oversight, and regulatory alignment of CMOs, CDMOs, and external consultants.
- Contribute to overall regulatory strategy and program‑level decision‑making.
- Identify regulatory risks related to CMC development and manufacturing and propose mitigation strategies.
- Stay current on evolving global CMC regulatory guidance and assess impact on development programs.
- Support inspection readiness and regulatory compliance activities as needed.
- Help establish scalable CMC regulatory processes appropriate for a growing biotech organization.
- Mentor and support junior regulatory or CMC team members as the organization expands.
- Represent the company with professionalism and credibility in external regulatory and scientific forums.
Qualifications
Required
- Bachelor’s degree in a scientific discipline (advanced degree preferred).
- 8+ years of experience in Regulatory Affairs with a strong focus on CMC.
- Demonstrated experience supporting IND and/or NDA/BLA submissions from a CMC regulatory perspective.
- Strong understanding of CMC requirements for drug substance and drug product development.
- Proven ability to work cross‑functionally and influence without authority.
- Excellent written and verbal communication skills.
Preferred
- Experience in clinical‑stage or early commercial biotech environments.
- Direct experience interacting with FDA and other global health authorities on CMC‑related topics.
- Familiarity with outsourced manufacturing models (CMOs/CDMOs).
- Experience supporting small molecule and/or biologic programs.
- Comfort working in an on‑site, highly collaborative setting.
Seniority level
Executive
Employment type
Full‑time
Job function
Science
Industries
Pharmaceutical Manufacturing, Chemical Manufacturing, and Biotechnology Research
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