Senior Regulatory Director

The Senior Regulatory Director provides strategic and operational regulatory expertise for Vivet`s programs, including with respect to product development, valuation, registration, and approval/post approval.

The Senior Regulatory Director defines and executes regulatory plans in line with the defined regulatory strategy. This is a strong leadership role responsible for ensuring compliance with regulations, while optimising interactions with regulatory authorities.  The Senior Regulatory Director must understand and challenge the dynamic regulatory landscape, while creating opportunities in the highly-regulated and complex environment, specifically for ATMPs & orphan diseases.

THE KEY FUNCTIONS OF THE SENIOR REGULATORY DIRECTOR INCLUDE:

  • Leading and providing strategic regulatory guidance and delivering the global regulatory strategy through product development, manufacturing and registration
  • Building and maintaining a credible relationship with regulatory authorities
  • Establishing an efficient repository and archive for correspondence compliant with regulatory standards for audits and due diligence
  • Responsible for ensuring high-quality, complete user/reviewer-friendly documents which are electronically transmissible and reproducible
  • Developing product information and target product profile for future product labels
  • Providing up-to-date regulatory intelligence, and participating in external industry partnerships
  • Ensuring published information and promotional/advertising material meet regulatory requirements e.g. in relation with patient adovcacy groups communication

REGULATORY STRATEGY:

  • Responsible for creation and implementation of regulatory strategies and managing operational AAV based gene therapy product activities
  • Responsible for implementing regulatory strategy and managing operational activities for EU and US (later Asia)
  • Definition of global regulatory strategy, including identification of gaps and risks/opportunities in global strategic plans
  • Leads interaction with regulatory consultants/advisors 

HA INTERACTIONS:

  • Sets requirements and objectives for Health Authority (HA) interactions
  • Coordinates and interacts directly with HAs
  • Facilitates preparation and finalization of briefing books.
  • Develops and implements plans for timely response to HA requests
  • Advises on optimal pediatric strategy and access to strategic designation e.g BKT, fast track, Prime, PRV etc.

SUBMISSIONS AND APPROVALS:

  • Responsible for identification of issues, gaps, and tradeoffs affecting optimal and timely submission and approval.
  • Generates and coordinates, plans, and prepares submission of dossiers
  • Responsible for high quality global dossier summary documents
  • Accountable for the development and implementation of plans to avoid/minimize clock stops during submission review
  • Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
  • Leads negotiations for Q&A and approvals

COMPLIANCE:

Ensures regulatory compliance for assigned project and keeps records of all major HA interactions int the validated document management system

Ensures quality and compliance with global regulatory requirements

MINIMUM REQUIREMENTS:

  • Advanced degree (Masters, PhD) in Pharmacy, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline is required
  • A breadth of regulatory experience with at least of 10 years of Regulatory Affairs experience in a biopharmaceutical company, including operational and management experience in clinical development, manufacturing, testing and distributing innovative pharmaceutical products
  • Alliance or co-development partnership experience is a plus
  • Demonstrated leadership participation with U.S. and international interactions, a working knowledge of FDA/EMEA regulations, the regulators, the submission and approval processes, and an excellent track record in building effective relationships with regulatory authorities
  • Experience in applying regulatory knowledge to various situations and serve as a source of competitive advantage to the Company.
  • A strong record of successful U.S. submissions for biologics and drugs which include INDs, CTDs, SA, Type B & C meeting; Annual Reports, Amendments, and Supplement DMFs, eventually MAA & BLAs
  • Experience in gene therapy or biologics desired
  • Excellent communication skills a must
  • Fluency in English as a business language. Additional language (French) is an asset.

This Position is located in Paris