Job Description

Location: Warren, NJ

Hybrid Position

My client is a global clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs. They are seeking a Head of Global Regulatory CMC to join their growing team.

Position: In this role, you will provide strategic leadership for the global regulatory efforts, guiding the development and execution of CMC strategies for complex biologic and drug-device combination products. The Head of Global Regulatory CMC will be responsible for authoring and driving submissions of critical regulatory documents, including IMPDs, INDs, BLAs, NDAs, CTAs, FDA briefing packages, and MAAs, ensuring the highest quality and compliance standards.

This is an exceptional growth opportunity to join a mission-driven team pioneering next-generation therapies for patients worldwide and to play a vital role in bringing transformative treatments to market.

KEY RESPONSIBILITIES:

• Point of contact for regulatory CMC expertise at health authority meetings and interactions.
• Prepare Module 3s of BLAs and MAAs for drug/device (patch) combination products for food allergies and prepare the CMC sections of INDs and IMPDs for early-stage products.
• Develop and coordinate CMC submissions to regulatory authorities, monitor progress, and coordinate written and verbal (during meeting) responses.
• Provide leadership, support, and expertise in preparing and finalizing all necessary manufacturing documents in support of IND, BLA, NDA, MAA, and other critical applications.
• Review CMC-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development.
• Closely Partner with internal stakeholders and external CDMOs/testing facilities to maintain inspection readiness and operational excellence.
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.

QUALIFICATIONS:

• Bachelor’s degree in life sciences or equivalent discipline is required; an Advanced degree (MS, PhD, PharmD) is strongly preferred. US RAC certification is a plus.
• Minimum of 10 years’ experience working in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents (e.g. FDA briefing books, IMPD, IND, BLA, NDA), and directly interfacing with health authorities (i.e. FDA, EMA).
• Critical ability to work closely with in-house Subject Matter Experts (SMEs) and Contract Manufacturing Organizations (CMOs) to acquire critical information in support of preparing the various segments of Module 3 and responses to Health Authority questions and issues.
• Demonstrated ability to supervise a Regulatory CMC staff and contract CMC Regulatory writers.
• Major capability to set, monitor, and meet CMC Module 3 and other Regulatory CMC timelines and deadlines.
• Experience in working with CMC Regulatory formats and templates for eCTD compilation of information and data displays.
• Prior experience participating in and writing documents for the FDA and other Health Authorities is required.
• Direct experience developing early and late-phase programs for combination products, biologics, and/or innovative technologies.
• Direct experience participating in cross-functional teams in a matrix environment.
• Experience working in both large pharmaceutical and small biotechnology organizations.
• Experience in building and managing a team of regulatory professionals.
• Experience providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams.
• Broad familiarity and current working knowledge of GxP (i.e., GMP, GDP, GCP).
• Understanding and working experience with biological products, combination products, and innovative products in early and late-phase clinical development.
• Strong verbal communication skills, with the ability to articulate CMC/regulatory concepts across line functions and to external audiences, are required.
• Ability to write high-quality regulatory documents (e.g., Briefing documents, IND amendments, IMPD, and other regulatory documents) is required.
• Experience with external and internal stakeholders to support global scientific and business strategies.
• Demonstrated working knowledge and experience of US, EU, and international regulatory requirements pertinent to this role.
• Exercise critical thinking, solution-oriented problem-solving, and strategic thinking skills, with the ability to impact and influence in a matrix environment and across functions. Strong analytical and business communication skills.

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