Director, Regulatory Affairs CMC

Description :

• Responsible for the development and execution of global regulatory CMC strategies and ongoing alignment with changing regulatory and business needs. This position will provide CMC regulatory expertise and leadership for combination biologics/medical device development projects and future commercial products.
• Lead CMC RA change control assessments, support of CDMO and QA manufacturing processes from CMC RA perspective, tracking of Health Authority commitments, leading global submissions and compliance to global regulations.
• Responsible for drafting, authoring, reviewing, and submitting key regulatory documents including Investigational Medicinal Product Dossier (IMPD), CMC sections of Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), U.S. Food and Drug Administration (FDA) briefing books/documents, Marketing Authorization Applications (MAAs), and other documents as needed.
• Work with both internal and external stakeholders to support inspection readiness and preparedness at both DBV and all CDMOs, and other contract testing facilities.
• Hybrid Role: Work from Warren, NJ office 3 days a week / 2 days from home. Additional days in the office as needed.
• Regular international Travel required - 15% of time

Veeva RIM experience is a must

Location :Warren, New Jersey - minimum 3 days on site

Salary Range :$190-230k

Key Responsibilities :

• Prepare Module 3s of BLAs and MAAs for drug/device (patch) combination products for food allergies including peanut allergy, celiac disease, and eosinophilic esophagitis plus 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.
• Review CMC-related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and as appropriate for the phase of development.
• Contribute to the implementation of regulatory 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; Advanced degree (MS, PhD, PharmD) preferred. US RAC and PMP certification 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
• 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 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 providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams.
• Broad familiarization 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 is required.
• Ability to write regulatory high-quality documents (e.g., Briefing documents, IND amendments, IMPD, and other regulatory documents, etc.) 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, strategic thinking skills with ability to impact and influence in a matrix environment and across functions.
• Strong analytical and business communication skills.
• Knowledge of French language is a strong plus
• Veeva RIM experience is a must

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.