Senior Director CMC Regulatory Strategy – Small molecules

Title:

Senior Director CMC Regulatory Strategy – Small molecules

Company:

Ipsen Innovation (SAS)

Job Description:

Job Title:     Sr Director CMC Regulatory Strategy – Small molecules

Division / Function:   Global Regulatory Affairs (GRA)

Manager (Name, Job Title):   Head of CMC Regulatory Strategy

Location:  Balard/ Paddington

Summary / purpose of the position

• Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders.
• Takes accountability/decision making for all Global CMC-Regulatory files in the small molecules cluster.
• Ensure the regulatory strategy related to CMC portion of Ipsen regulatory submissions for all small molecules portfolio worldwide is developed and implemented from early clinical trials to initial marketing applications, geo-graphical expansion, and life cycle management. Ensure timely and compliant submissions of CMC dossiers through efficient processes according to company’s strategy, business need and patients ‘interests. 
• Accountable for early communication and validation from worldwide health authorities for any CMC strategic program and/or CMC questions across the small molecules portfolio’s life cycle, in order to generate effective CMC regulatory dossiers and optimize time to market of new product and related changes.
• Accountable for ensuring compliance of CMC dossier of Ipsen’s products in all territories where Ipsen is the Marketing Authorization Holder.
• Accountable and responsible for delivering a transparent Governance structure for CMC regulatory operations ensuring the inclusion of upper management stakeholders within the Pharmaceutical Development, and Technical Operations teams.
• Provide strategic and operational leadership to his/her team and to R&D and TechOps upper management stakeholders; leading CMC regulatory interactions, preparation of submission dossiers, and active engagement with global/external CMC strategy forums and new guidelines in order to influence the regulatory environment.

Main responsibilities / job expectations

• CMC Regulatory strategy
  • Work closely with global Ipsen regulatory community and particularly with Ipsen Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of Ipsen small molecules’ portfolio (opportunities for ODD, fast track, breakthrough status, etc).
  • Accountable for the definition and execution of the CMC regulatory strategy for new products in development and commercial assets; ensuring alignment with clinical programs and ensuring that regulatory requirements are met.
  • Continuously evaluate the match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with R&D, Tech Ops, Operations and Project Teams, ensure plan adaptation when needed. Assess impact on timelines and/or supply; proposes remediation where possible.
  • Ensure coherence of strategies across projects of Ipsen small molecules’ portfolio for worldwide submissions.
  • Ensure regional regulatory specificities and needs are incorporated into the global plans.
  • Bring innovative and compliant CMC regulatory pathway in the development of Ipsen small molecules’ portfolio.
  • Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making.
  • Define and execute strategy for early regulatory communication with worldwide Authorities and seek validation of innovative CMC regulatory strategy with Regulatory Agencies and CMCs KOL, maintaining active engagement with new guidelines.
  • Accountable for the CMC regulatory section of briefing documents for regulatory positioning and justification in collaboration with the SMEs.
  • Review of the Target Product Profile (TPP & QTPP)/ Regulatory risk assessment/ Regulatory Strategy Document/ CCDS to ensure single aligned regulatory positioning and appropriateness of any CMC aspects, including pediatric (presentation, formulation, excipients) and ROW considerations.
  • Incorporate commercialization challenges into regulatory strategy (incl. trademark, licensing agreements, product sourcing, supply chain, distribution channels) beyond Marketing Authorizations (BLA etc).
  • Consider regulatory avenues to maximize intellectual property protection and data exclusivit