Head of Affiliate Regulatory and Pharmacovigilance CEERTMEA

Your Role: Head of Affiliate Regulatory & Pharmacovigilance, CEERTMEA

As Head of Affiliate Regulatory & Pharmacovigilance, CEERTMEA, you will lead all regulatory affairs and pharmacovigilance activities for Elanco's CEERTMEA operations, ensuring compliance and strategic product lifecycle management. In this role, you’ll be responsible for developing and executing robust regulatory strategies for both existing and new products, and for leading pharmacovigilance processes to ensure product safety and efficacy.

Your Responsibilities:

• Regulatory Strategy & Execution: Develop, implement, and manage comprehensive CEERTMEA regulatory strategies for the lifecycle management of registered products (e.g., variations, renewals, line extensions) and new product registrations in non-EU countries. This includes acting as the primary point of contact with regulatory agencies, providing expert regulatory intelligence to cross-functional teams, proactively monitoring legislation changes, and leading the preparation and submission of high-quality technical packages.
• Pharmacovigilance (PV) Oversight: Ensure full PV compliance in CEERTMEA with local, global, and internal requirements, including audit and inspection readiness. This involves line management of the CEERTMEA PV Team, building relationships with external stakeholders, collaborating with Elanco GPV, ensuring appropriate training, and supporting new product launches.
• Leadership & Team Management: Lead, mentor, and develop a high-performing team of regulatory and pharmacovigilance professionals, fostering a culture of accountability, continuous improvement, and strong ethical conduct. This also includes managing departmental resources and representing CEERTMEA's regulatory and PV interests in regional and global forums.
• Cross-functional Collaboration & Business Partnership: Serve as a key strategic partner to CEERTMEA Commercial, Marketing, Legal, and Quality teams, integrating regulatory and PV perspectives into business planning and decision-making. This involves providing critical input into commercial sales activities and facilitating effective communication and collaboration across global functions.
• Quality & Compliance: Ensure all regulatory and PV activities adhere to Elanco's Quality Management System (QMS), Standard Operating Procedures (SOPs), and relevant industry best practices. This includes properly maintaining all regulatory, pharmacovigilance, and legal documentation, and driving continuous improvement initiatives within the CEERTMEA region.

What You Need to Succeed (minimum qualifications):

• Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
• A minimum of 10+ years of proven experience in Veterinary Medicine/Pharmaceutical Regulatory Affairs within a reputable global or local pharmaceutical company.
• Exceptional leadership, strategic thinking, and problem-solving abilities; Strong communication, negotiation, and influencing skills.

What will give you a competitive edge (preferred qualifications):

• Ability to build strong relationships and collaborate effectively across diverse functions.
• Demonstrated resilience and ability to maintain focus under pressure.
• Proactive change agent, adept at driving transformational initiatives.
• Proficiency in additional languages from the CEERTMEA region.

Don’t meet every single requirement? Studies have shown underrecognized 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. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!