Director Regulatory CMC Strategy (H/F)
Title:Director Regulatory CMC Strategy (H/F)
Company:Ipsen Innovation (SAS)
Le laboratoire IPSEN recrute un Director Regulatory CMC Strategy. Rattaché à la direction des affaires réglementaires, vous serez le spécialiste de la stratégie CMC pour les produits en développement, en neurologie et/ou oncologie.
Department: Global Regulatory Affairs (GRA)
Location of the role: Les Ulis (site IPSEN R&D)
Purpose of the position
- Build early CMC regulatory Strategy for assigned projects aligned with pre-clinical and clinical programs.
- Take responsibility to propose early communication and validation from worldwide health Authorities for any CMC strategic program and/or CMC questions to project teams, Subject Matter Experts (SMEs) and regulatory product lead.
- Collaborate with Pharmaceutical development and Tech Ops teams in order to generate CMC regulatory Dossiers to optimize time to market of new products/projects.
- Provide CMC regulatory expertise to R&D project teams.
CMC Regulatory strategy
- Work closely with 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 all assigned projects (opportunities for ODD, fast track, break through status…).
- Define and execute the CMC regulatory strategy for new products ensuring the alignment with clinical program and ensuring also that the regulatory requirements are met.
- Ensure coherence of strategies across projects of the assigned portfolio.
- Ensure regional regulatory specificities and needs are incorporated into the global plans.
- Bring innovative and compliant CMC regulatory pathway in the development of Ipsen portfolio.
- Establish early communication with worldwide Authorities and seek validation of innovative CMC regulatory strategy with Regulatory Agencies and CMCs KOL.
- Responsible 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)/ 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.
- Collaborate with Intellectual property teams and Ipsen regulatory community to investigate regulatory pathway to maximize intellectual property protection and data exclusivity.
CMC dossiers preparation
- Ensure collaboration with teams in Pharmaceutical development and Subject Matter Experts (SME) to deliver effective, timely and compliant CTA (IND, IMPD) and MAA modules 2 & 3 in the correct format “Ready For Submission” for new products in compliance with eCTD requirement and Ipsen Group Regulatory Affairs Dossier Management rules as required.
- Accountable for the CMC dossier generation process across all functions: ensure the role of each function involved in the generation of the CMC dossier is clear and will provide the right data with the correct level of detail in compliance with regulatory requirement.
- Manage timely and efficiently the Response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical development teams and Subject Matter Experts (SMEs) as necessary to reach submission approval
CMC Regulatory expertise & Regulatory intelligence
- Participate and represent CMC regulatory strategy department in CMC project teams and Global project team, as necessary, for the assigned projects
- Provide Ipsen function (e.g. pharm Dev, SMEs, GRA, Global project teams...etc.) with CMC regulatory expertise.
- Communicate key regulatory CMC related guidance’s to Pharmaceutical development teams, SMEs and other stakeholders within Ipsen
- Monitor the external environment to identify trends and assess potential impact on business and communicate this information to stakeholders.
- Represent Ipsen CMC regulatory in Industry associations or working groups and ensure company’s interests are taken into account.
- Lead and develop a team part of the regulatory strategic CMC Group
- Lead and manage assigned projects and associated reporting/ communication
- Establish and maintain an excellent working relationship with Pharm dev teams and the Ipsen regulatory community, in particular Ipsen Global Regulatory Affairs Therapeutic Area Leads, European and intercontinental leads, Regulatory Operations Publishers and Ipsen affiliates/partners to ensure efficient coordination of regulatory submissions.
- Build effective relationships with global/regional regulators through agencies meetings, scientific advices and scientific workshops to ease validation on Ipsen strategy
- Actively contribute to the Regulatory Community life.
Experience / Qualifications
- Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science)
- At least seven to ten years pharmaceutical experience with at least five years in CMC regulatory R&D environment in a management role
Key Required Technical Competencies
- Proven experience in managing complex products (biological and non biological products, medical devices, peptides/ proteins/ toxins…) in a worldwide environment
- Proven experience in CMC regulatory on R&D portfolio
- Proven advanced technical and regulatory writing experience with pharmaceuticals
- Proven ability to lead teams and earn respect in a cross-functional global environment
- Proven understanding of CMC regulatory processes and requirement in US, EU, JP, China
- Excellent written, verbal and interpersonal communication skills, highly organized
- Strong analytical and problem-solving skills
- Language: English: fluent; French: preferred