Senior Manager, CMC Regulatory Strategy

Responsibility for CMC regulatory strategy for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, geographical expansion, and life cycle management. To manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen’s GRA LT, manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO) SMEs and LT, Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy. Provide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers and support the development of junior CMC-reg colleagues.

Main Responsibilities & Technical Competencies

• CMC Regulatory Strategy
  • Lead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects ensuring the CMC reg risks are identified, assessed & shared as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met.
  • Work efficiently with CMC regulatory senior management to ensure coherence of strategies across projects.
  • Lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams.
  • Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
  • Define and execute the CMC regulatory strategy roadmaps for all products in scope ensuring that regulatory requirements are met.
  • Ensure regional regulatory specificities and needs are incorporated into the global plans including emerging regulations.
  • Participate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks.
  • Propose innovative CMC regulatory pathways to accelerate product delivery for patients, as required.
  • Communicate with global regulatory lead to propose de-risking through early communications with worldwide health authorities.
  • Lead the CMC regulatory section preparation 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 / Investigational brochures to ensure single aligned regulatory positioning and appropriateness of any CMC aspects.
  • Assess CMC-Regulatory impact of all changes proposed to the allocated product portfolio, providing strategic regulatory advice.
  • Contribute to the development and maintenance of efficient, compliant and robust systems, procedures and processes.
  • Manage all Regulatory interactions for Site Registrations, Site Licences, Site master files, annual reports and site accreditations with Regulatory Authorities.
• CMC Dossier Preparation
  • Ensure collaboration with teams in Pharmaceutical Development/ Technical Operations and Subject Matter Experts (SME) to deliver effective, timely and compliant CTA (IND, IMPD) and MAA modules in the correct format.
  • Write regulatory technical documentation including updating CTD sections with process and analytical data.
  • Responsible for the CMC dossier generation process across all functions.
  • Manage timely and efficiently the Response to CMC questions from National Health Authorities worldwide.
  • Prepare and maintain the necessary CMC trackers, monitor progress using KPIs and provide regular updates to the team.
• CMC Regulatory expertise & Regulatory intelligence
  • Participate and represent CMC regulatory strategy department in CMC project teams and Global project team.
  • Proactively provide Ipsen functions with CMC regulatory expertise.
  • Communicate key regulatory CMC related guidance’s to stakeholders within Ipsen.
  • Participate in the monitoring of the external environment to identify trends and assess potential impact on business.
  • Actively participate in Industry associations or working groups.
• Resources and performance
  • Coach and develop junior resource within the regulatory strategic CMC Group.
  • Lead and manage assigned projects and associated communication and reporting.
  • Monitor and report on CMC Regulatory activities and process performance for the allocated products.
• Communication
  • Establish and maintain an excellent working relationship with Pharm Dev/ TechOps teams and the Ipsen regulatory community.
  • Lead contact with external Alliance partners and CMOs ensuring aligned strategy and optimised communication.
  • Build effective relationships with global/regional regulators through agencies meetings and scientific workshops.
  • Ensure the CMC-Regulatory Strategy Director/Senior Director is provided with accurate and up-to-date CMC-Regulatory strategy for the assigned product(s).
  • Actively contribute to the Regulatory Community life.

Behavioural Competencies Required

• Puts values and ethics at the forefront of everything.
• Identifies contradictory information/demands/inputs to effectively solve problems.
• Develops and evaluates alternative scenarios and solutions.
• Able to identify what truly matters and ruthlessly focus on making decisions with real impact.
• Methodically assesses, transparently shares, and makes risk-informed decisions.
• Displays a commitment to sharing and implementing best practices and committed to excellence in execution.

Knowledge & Experience (essential)

• Proven direct experience in CMC regulatory environment in pharmaceutical industry (approximately 8 - 10 years’ experience).
• Proven experience in managing CMC-regulatory activity for products in a worldwide environment.
• Proven experience in CMC regulatory on R&D and LCM portfolio.
• Experience of Health Authorities interaction.
• Proven advanced technical and regulatory writing experience with pharmaceuticals.
• Excellent written, verbal and interpersonal communication skills, highly organized.
• Strong analytical and problem-solving skills.

Education / Certifications (essential)

• Advanced degree in scientific discipline (such as Pharmaceutical/ Medical/ Biological/ Chemical Science).

Language(s) (essential)

• English: fluent.