Vice President of Regulatory Affairs (Project Management)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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: Vice President of Regulatory Affairs
The VP of Regulatory Affairs is a critical leadership role within Elanco, responsible for overseeing and strategically directing all regulatory activities for the organization. This includes setting and executing the global regulatory strategy, ensuring compliance with all applicable regulations, and leading interactions with regulatory agencies worldwide – all in a resource-optimized way, while leveraging digital/technological advances. This role requires a deep understanding of the animal health industry, extensive experience leading multi-functional and multi-national teams, and a proven track record of successful regulatory submissions and approvals.
Your Responsibilities:
- Lead the development and execution of a comprehensive global regulatory strategy, including team and resource management, aligned to Elanco's business objectives. Build and lead a high-performing regulatory affairs team, fostering a culture of collaboration, excellence and continuous improvement to effectively execute that strategy.
- Oversee all global regulatory submissions, ensuring timely and high-quality dossiers for worldwide agencies.
- Lead interactions and negotiations with global regulatory authorities, such as the FDA and EMA.
- Ensure compliance with all applicable regulations (e.g., GMP, GLP, GCP) and provide expert guidance to cross-functional teams.
- Proactively monitor and adapt to changes in the global regulatory landscape.
What You Need to Succeed (minimum qualifications):
- Education: Advanced degree in a scientific discipline (e.g., DVM, PhD) preferred.
- Experience: A minimum of 10 years of experience in regulatory affairs within the animal health industry.
- Demonstrated ability to develop and implement successful regulatory strategies and proven experience leading and managing multi-functional and multi-national teams. Excellent communication, negotiation, and interpersonal skills.
What will give you a competitive edge (preferred qualifications):
- Strong understanding of global regulations and guidelines related to animal health products.
- Experience designing and running large parts of a corporate R&D organization.
- Experience in regulatory affairs within the companion animal, livestock, vaccines, and/or pharmaceuticals sectors.
Additional Information:
- Travel: 30-40% domestic and international travel required
- Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work Environment
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!
Elanco Benefits and Perks:
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
