Director, CMC Regulatory Affairs - Biologics

At DBV Technologies, we celebrate full expression of our four core values and their associated professional behaviors. Also known as the 4Cs, these values - Curiosity, Courage, Collaboration and Credibility - are rooted in the DNA of our company.

With roots in France, and a strong American and Australian presence, our ambition is global. Do you want to join an ambitious biotech company where employees are passionate about science and innovation?

Join us at DBV Technologies!

POSITION OVERVIEW:

• The Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) will be 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.
• The Director of Regulatory Affairs CMC will be 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.
• The incumbent will also represent DBV at global health authority meetings where CMC matters/topics are being discussed, including those with the FDA and the European Medicines Agency (EMA), and other Agencies as required.
• The incumbent will have responsibility for working with both internal and external stakeholders to support inspection readiness and preparedness at both DBV and all CDMOs, and other contract testing facilities.

MAIN ACTIVITIES:

• 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.
• Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Represent DBV for regulatory CMC expertise at health authority meetings and interactions.
• Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications to current and future development and commercial activities.

INTERNAL AND EXTERNAL RELATIONS:

• Internal: Regulatory Affairs, Quality Assurance and Control, Technical Operations, Biostatistics, and Medical Affairs
• External: Regulatory agencies, CDMOs, testing facilities, consulting partners and contractors

REQUIRED SKILLS:

Technical / scientific skills:

• 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.

Competencies: 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.