About the role

  • Develop, in collaboration with the CMC team, the CMC development plan up to the Marketing Authorization Application (MAA).
  • Propose innovative CMC regulatory strategies.
  • Ensure integration of regional regulatory specificities into global CMC plans.
  • Identify and assess CMC regulatory risks.
  • Participate in CMC project teams, global project teams and regulatory project teams.
  • Prepare briefing documents related to regulatory positioning.
  • Assess the regulatory impact of proposed changes to assigned products.

Requirements

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

Benefits

  • Incentives
  • Profit-sharing
  • Employee share ownership plan in Pierre Fabre with employer contribution
  • Health insurance and welfare coverage
  • 16 RTT days in addition to 25 days of annual leave
  • Commuter/transport allowance
  • Attractive Works Council (employee benefits) offerings

Job title

Regulatory CMC Development Expert

Job type

Experience level

SeniorLead

Salary

Not specified

Degree requirement

Postgraduate Degree

Tech skills

Location requirements

Report this job

See something inaccurate? Let us know and we'll update the listing.

Report job