Elanco
Global Regulatory Project Lead - Global Regulatory Affairs
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Global Regulatory Project Lead - Global Regulatory Affairs
## Global Regulatory Project Lead – Global Regulatory Affairs
At Elanco (NYSE: ELAN)
Our mission at Elanco is driven by the commitment to prevent and treat disease in farm animals and pets. As a global leader in animal health, we focus on innovation, sustainability, and societal impact—just as our vision declares: Food and Companionship Enriching Life.
We cultivate a diverse and inclusive workplace to fuel creativity, innovation, and career growth. If you thrive in a dynamic, forward-thinking environment, join us in making life better for animals—and for people too!
About the Role
As the Global Regulatory Project Lead, you will:
- Develop and execute global regulatory strategies for pre-approval and post-launch compliance.
- Lead cross-functional teams to ensure seamless alignment with regulatory agencies (EU, USA, and other key markets).
- Oversee license registration submissions, ensuring timelines, budget, and compliance are met.
- Bridge regulatory insights into key business decisions, shaping product development and go-to-market strategies.
Closely collaborate with:
- Global R&D teams
- Sales & Marketing partnerships
- Supply Chain, Manufacturing, Quality, Legal, and Technical Services
You’ll drive innovation in registration processes, strengthening Elanco’s global footprint while championing animals—and the people behind them.
Key Responsibilities
Strategy & Technical Leadership
- Design and refine global regulatory strategies aligned with business objectives
- Lead technical documentation creation for development projects
- Ensure timeliness of compliance and project execution
Agency Engagement & Relationships
- Lead EU & US regulatory interactions with Health Authorities (linked to broader global coordination)
- Build strong collaborative relationships with key regulatory agencies
- Participate in regulatory summits & associations to advance novel approaches
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Project Oversight & Risk Management
- Prioritise resource allocation to meet deadlines and objectives
- Identify, mitigate, and communicate regulatory and cross-functional risks
- Apply risk assessment frameworks to strategic decision-making
Cross-Functional Collaboration
- Represent regulatory needs in product development & governance discussions
- Advise on target product profiles and registration dossiers
- Engage with R&D, Marketing, Legal, and Manufacturing to align strategies
- Guide clinical trial planning and compliance reviews
Clinical & Quality Compliance
- Foster alignment between R&D and regulatory policies
- Author/review SOPs, guidance documents, and compliance frameworks
- Ensure adherence to National Competent Authority (NCA) regulations
Meeting Leadership
- Chair technical discussions: Regulatory agency meetings & stakeholder clarifications
- Support thorough preparation and challenge resolution during interactive reviews
Policy & Ethics Compliance
- Uphold all local and global Elanco policies, including:
- Quality frameworks
- Code of Conduct
- Anti-discrimination & anti-harassment safeguards
- Health, Safety, and Environment (HSE)
What You Need to Succeed
Education
- Master’s degree or higher in:
- Veterinary Medicine
- Biology, Immunology/Infectious Diseases, or related life sciences
Relevant Experience
- 10+ years in animal health regulatory sectors, with key experience in:
- Pharmaceutical, Biological, and/or Nutritional products registration
- Regulatory Affairs, operational leadership, and dossier registration
- Prefer proven leadership tracking product approvals across multiple geographies
Technical Knowledge
- Deep understanding of:
- Global regulatory processes for veterinary medicine
- Multi-country submission systems and registration timelines
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Critical Skillset
- Strong grasp of risk assessment and applicable tools
- Proven ability to make impactful decisions under ambiguity
- Active networking skills for business development (internal & external)
- Proficiency in interpersonal communication, influence, and diplomacy
Senior Leadership Traits
- Demonstrated ability to navigate conflict with courage and confidence
- Coach and commercialise insights without compromise
Why Stand Out?
Preferred Qualifications
- Knowledge of Lean/Six Sigma and Continuous Improvement methodology
- Experience in novel regulatory pathways (e.g. accelerated, innovative science frameworks)
Additional Information
- Travel: 0–10%
- Location:
- DE – Monheim (Germany, Office & Hybrid)
- BE – Antwerp (Belgium, Office & Hybrid)
- UK – Hook (near Salisbury, Office & Hybrid)
- Career Growth: Elanco values hybrid collaboration and skill development to advance your career trajectory.
Elanco’s Diverse Commitment
We recognise that talent thrives beyond ‘perfect’ resumes—skilled and diverse minds drive our mission.
If you believe you align with this role’s core needs, apply even if you don’t match every listed requirement.
Elanco is Equal Opportunity / Affirmative Action—committed to fostering fairness in recruitment.
Elanco Workforce Privacy Notice: Learn how We Handle Personal Data.
More About Elanco
With 70+ years of dedicated animal health expertise, we partner with customers to safeguard wellness—for farmers, pets, and ecosystems alike.
- Fields: Preventative care, disease treatment, and sustainability.
- Philosophy: Food and Companionship Enriching Life™—creating value and impact globally.
Visit elanco.com to discover our global impact and our Elanco Healthy Purpose™ mission.
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