Pharmaceutical Affairs Manager/ Deputy Responsible Pharmacist, France & Benelux

Why Join Us?

Be a hero for our rare disease patients

At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. 

Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.

If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

Working directly with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux, the Pharmaceutical Affairs Manager / Deputy Responsible Pharmacist, will manage the quality system and ensures compliance with applicable pharmaceutical regulations for the French & Benelux cluster. This position will require close collaboration with the European Qualified Person and Global QA.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Manage and maintain the Quality System for the Cluster
• Ensure compliance of promotional activities to applicable standards (e.g. LEEM Charte, HAS reference standards,…)
• Definition, implementation, monitoring of audits plan and monitoring of subcontractors involved in pharmaceutical activities
• Ensure readiness for Inspections by competent authorities or audits
• Ensure deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking are processed and tracked accordingly
• Review packaging materials, promotional and non-promotional materials
• Coordinate initial and continuous training for employees, including tracking, monitoring of knowledge acquisition and archiving
• Serve as a backup for additional responsibilities the Pharmaceutical Affairs department.
• In addition, the Pharmaceutical Affairs Manager will act as Deputy Responsible Pharmacist, to cover periods when the Responsible Person is unavailab
• According to article R-5124-34 and R- 5124-36 of the French Public Health Code, the Responsible Pharmacist position covers a broad area of responsibilities as Regulatory (Marketing Authorization and labelling), Quality (Complaints, Batch traceability and batch recalls, Manufacturing/Distribution/Storage/Transport of medicinal products), Import/Export activities, Pharmacovigilance, Advertising, Medical information related to the “Exploitant” status and participation in Research & Development activities.

Requirements:

• Pharmacist diploma, with fluent French and English language skills.
• Qualification as Deputy Responsible Pharmacist and at least 2 years’ experience in that role.
• 5-10 years’ experience in Quality Assurance
• 6-12 months experience in Pharmacovigilance and batches follow up.
• Knowledge of GxP’s, with a high focus on French and European regulations, GMP, GDP and GVP.
• Travel <20 % #LI-CK1 #LI-Onsite

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: [email protected].

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