Pharmaceutical Affairs Specialist
il y a 2 semaines
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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