Director of Global Regulatory Affairs

4 weeks ago

Greenfield IN USA, United States Elanco Full time
About the Role

At Elanco, we are seeking a highly skilled and experienced Director of Global Regulatory Affairs to lead our pharmaceutical innovation efforts. As a key member of our team, you will be responsible for developing and implementing global regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with relevant laws and regulations.

Key Responsibilities
  • Design and develop creative global regulatory strategies and technical regulatory documents based on interpretation of both regulatory and scientific information.
  • Lead the preparation and execution of project meetings with regulatory authorities and other external partners/customers, maintaining positive relationships with those parties.
  • Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review.
  • Lead the delivery of compliant commercial labels during the pre-launch phase across major geographies (EU/US), ensuring timely market access and regulatory compliance.
Requirements
  • Minimum master's degree; DVM or PhD highly desired.
  • A minimum of 5 years of experience in animal health industry (companion animal health preferred).
  • Regulatory affairs experience, and understanding of the animal health industry and the animal drug development process.
Preferred Qualifications
  • More years of experience in the industry.
  • DVM or PhD.
  • Strategic thinking and ability to design and develop innovative global regulatory strategies.
  • Effective collaboration and skills in collaborating with cross-functional teams.
About Elanco

Elanco is a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We are driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy PurposeTM – to advance the health of animals, people, the planet and our enterprise.

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose. Some highlights include:

  • Multiple relocation packages.
  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO).
  • 8-week parental leave.
  • 9 Employee Resource Groups.
  • Annual bonus offering.
  • Flexible work arrangements.
  • Up to 6% 401K matching.

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.

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