Hybrid Regulatory CMC Development Expert – CDI

Posted last week

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About the role

  • Regulatory-CMC Development Expert supporting strategic projects at Pierre Fabre, a leader in dermo-cosmetics and pharmaceuticals. Responsible for CMC regulatory strategy from early clinical trials to marketing applications.

Responsibilities

  • Responsable for the CMC regulatory strategy for assigned projects
  • Provide CMC regulatory expertise to the pharmaceutical development team
  • Develop the CMC development plan in collaboration with the pharmaceutical CMC team
  • Propose innovative CMC regulatory pathways
  • Ensure that regional regulatory requirements are integrated into global CMC plans
  • Identify and communicate CMC regulatory risks
  • Manage preparation of briefing documents for regulatory positioning
  • Assess the CMC regulatory impact of all proposed changes for the assigned product

Requirements

  • Master's degree or equivalent scientific qualification
  • Minimum of 8 years of relevant professional experience, preferably in CMC regulatory development or CMC R&D
  • Knowledge of small molecules and biologics is a plus
  • Ability to work independently and as part of a team
  • Strong stakeholder engagement skills with internal and external partners
  • Good written, verbal, and interpersonal communication skills
  • Highly organized
  • Familiarity with Veeva Vault RIM or similar regulatory tools is a plus
  • Proficiency in English is required
  • Ability to work in an international environment

Benefits

  • Incentive schemes
  • Profit-sharing
  • Pierre Fabre employee share ownership plan with employer contribution
  • Health insurance and welfare benefits
  • 16 additional RTT days plus 25 paid leave days
  • Public transportation subsidy
  • Very attractive employee benefits committee (CE)

Job title

Regulatory CMC Development Expert – CDI

Job type

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Postgraduate Degree

Tech skills

Location requirements

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