Sr. Director, Global Regulatory Affairs – Pharmaceuticals Full Time

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description

To lead the US Pharmaceuticals team in the development of regulatory strategy, guide submission preparation and ensure the team is meeting the reporting requirements for the approval of new animal drugs and specified lifecycle management (claim extensions, new species, etc) of marketed animal drugs governed by the CVM and EPA in the United States.

To engage with the relevant R&D, Regulatory and Commercial leadership to ensure aligned priorities and appropriate coverage of all prioritized activities in support of the US.

To serve as the main point of contact with the CVM and represent Elanco on key AHI Working Groups.

To directly support key US Innovation projects from early development through registration, as needed.

To directly manage and develop a team ensuring resources are appropriately allocated to support business needs. 

To foster a positive, creative, psychologically safe work environment within the US Pharmaceuticals team and the broader Global Regulatory Affairs organization.

Functions, Duties, Task

• Lead team to execute pharmaceutical and biocide regulatory submissions in the US.
• Lead team to provide regulatory guidance/consultancy to the commercial business and R&D organizations on US submission strategies for innovation products.
• Manage submission planning and tracking of US regulatory procedures for innovation and lifecycle management products.
• Prioritize submissions where resource constraints require, in collaboration with other functions.
• Act as a point of contact for US regulatory authorities.
• In collaboration with Regulatory Policy and Intelligence group, lead team to participate in industry associations to influence adoption of best practices in animal health regulatory advocacy programs critical to Elanco business success.
• Develop talent to sustain regional & global competitiveness. Includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

Minimum Qualification (education, experience and/or training, required certifications)

• Bachelor’s Degree with at least 10 years relevant work experience within the Animal Health Industry
• Experience working with global regulatory agencies
• Strong communication skills, both written and oral
• Ability to make decisions when there is no clear right or wrong answer
• Self-starter, takes initiative
• Previous management experience
• Strong organization skills

Additional Preferences:

Select and define as appropriate;

• Direct experience negotiating with US Health Authorities
• Languages: Fluency in English (verbal and written)

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

Alternatively, you can view other roles for reentry opportunities at https://reentrycareers.com/

Tagged as: Freelance