Pharmaceutical Affairs Specialist

il y a 2 semaines


Paris, Île-de-France Ultragenyx Pharmaceutical Temps plein

Ultragenyx Pharmaceutical is seeking a dedicated and experienced Pharmaceutical Affairs Manager / Deputy Responsible Pharmacist to join our growing team in France.

Reporting directly to the Responsible Pharmacist and Director of Pharmaceutical Affairs for France & Benelux, you will play a crucial role in ensuring compliance with pharmaceutical regulations and maintaining the highest quality standards within our operations.

Your Responsibilities:

  • Oversee and maintain the effectiveness of our Quality Management System.
  • Guarantee that all promotional activities adhere to industry best practices and regulatory guidelines.
  • Develop and execute audit plans, monitoring subcontractors involved in pharmaceutical processes.
  • Prepare for and manage inspections and audits from regulatory bodies.
  • Handle deviations, change controls, risk assessments, CAPAs, recalls, and product returns efficiently and effectively.
  • Review packaging materials and promotional content to ensure compliance.
  • Coordinate training programs for employees on relevant pharmaceutical regulations and procedures.
  • Provide backup support within the Pharmaceutical Affairs department as needed.

Your Qualifications:

  • Possess a Pharmacist diploma with fluency in both French and English.
  • Hold a qualification as Deputy Responsible Pharmacist and have at least 2 years of experience in this role.
  • Demonstrate 5-10 years of proven experience in Quality Assurance within the pharmaceutical industry.
  • Have 6-12 months of experience in Pharmacovigilance.
  • Possess a strong understanding of GxP guidelines, French, and European pharmaceutical regulations.
  • Be willing to travel less than 20% of the time.

We Offer:

  • Generous vacation time and public holidays.
  • Long-term incentive and stock purchase plans.
  • Comprehensive employee wellbeing benefits.
  • Fitness reimbursement programs.
  • Tuition sponsoring opportunities.
  • Professional development plans to support your growth.


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