Local Pharmacovigilance Manager & Regulatory Manager

Elanco

Paris

On-site

EUR 90,000 - 130,000

Full time

11 days ago

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Job summary

Elanco Animal Health is seeking a Local Pharmacovigilance Manager and Regulatory Manager in France to lead local PV activities and maintain regulatory compliance for the portfolio. You will serve as the French affiliate's key PV contact, oversee AE and product complaint reporting, coordinate audits, and collaborate with European and global teams to ensure timely regulatory submissions and MA maintenance.

Fluent French and English, a veterinary degree for PV responsibilities, and strong

Qualifications

  • University-level education in a pharmaceutical or life-science discipline.
  • Veterinary degree required for pharmacovigilance responsibilities.
  • Experience in pharmacovigilance and knowledge of French regulatory affairs.
  • Excellent written and verbal communication; fluent French and English.

Responsibilities

  • Act as the local point of contact for Pharmacovigilance within the French affiliate.
  • Maintain and oversee the local pharmacovigilance system with AE and product complaint reporting.
  • Coordinate PV audits and inspections; liaise with EU QPPV and global teams.
  • Provide regulatory guidance to the business and interact with Regulatory Authorities.
  • Plan regulatory activities for assigned products, including new registrations and MA maintenance.
  • Submit variations and regulatory documentation to ensure ongoing compliance.
  • Collaborate with cross-functional teams across local, European and global Elanco groups.

Skills

Pharmacovigilance
Regulatory affairs
French language
English language
Communication skills

Education

Pharmaceutical or life-science degree
Veterinary degree
Regulatory knowledge

Job description

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today!

Your role:

In this combined Pharmacovigilance (PV) and Regulatory Affairs (RA) role, you will act as the local representative of the Elanco Pharmacovigilance organization in France while ensuring the regulatory compliance of our product portfolio. As Local Pharmacovigilance Manager (LPVM), you will lead local pharmacovigilance activities, maintain the local PV system and ensure compliance with French regulatory and Elanco requirements. As Regulatory Manager (RAM), you will manage regulatory activities for assigned products, maintain existing Marketing Authorizations and contribute to new registrations in France.

Your Responsibilities:
  • Act as the key local point of contact and provide leadership for all Pharmacovigilance matters within the French affiliate.
  • Maintain and oversee the local pharmacovigilance system, ensuring compliant management and reporting of Adverse Events (AEs) and Product Complaints (PCs).
  • Manage PV-related communication with Regulatory Authorities and ensure appropriate training, documentation and ongoing compliance with local and Elanco requirements.
  • Coordinate PV audits and inspections, maintain inspection readiness and work closely with the EU QPPV, Global PV and Quality teams on product safety and risk management activities.
  • Manage relationships and interactions with relevant Regulatory Authorities and provide regulatory guidance to the business.
  • Plan and coordinate regulatory activities for assigned products, including new registrations and maintenance of existing Marketing Authorizations (MAs).
  • Ensure ongoing regulatory compliance through timely submission of variations, change controls and other required regulatory documentation, including compliance of product information and promotional materials.
  • Partner with local, European and global cross-functional teams and proactively identify opportunities to improve product safety, regulatory compliance and operational efficiency.
What You Need to Succeed (minimum qualifications):
  • University-level education in a pharmaceutical or life-science discipline, such as veterinary medicine/pharmacy, or a comparable qualification supported by relevant professional experience.
  • Veterinary degree required for the Pharmacovigilance responsibilities.
  • Experience in Pharmacovigilance activities Knowledge of French Regulatory Affairs legislation.
  • Excellent written and verbal communication skills.
  • Fluent French and excellent written and spoken English.
What will give you a competitive edge (preferred qualifications):
  • Experience working effectively across different functions and within an international environment.
  • Strong personal accountability and ability to independently drive activities to completion.
  • Excellent attention to detail and a strong analytical mindset.
  • Proactive approach to identifying opportunities for process, compliance and efficiency improvements.
Additional Information:

This position combines key responsibilities across Pharmacovigilance and Regulatory Affairs in France and requires close collaboration with local, European and global Elanco teams, Regulatory Authorities and external partners. Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.

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