Sr. Director, Regulatory Affairs - Biological Vaccines, NA

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:

This role is responsible for leading and overseeing the regulatory activities, both pre- and post- approval, for biologicals in the US and Canada, working collaboratively with key stakeholders i.e. Global Regulatory, Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, Technical Services, to ensure regulatory compliance.

Functions, Duties, Task:

• Technical and strategical leadership and administration of the North American Regulatory Biologicals team
• Lead, facilitate and enable the design and development of regulatory strategy and technical regulatory documents in support of global biologicals development projects as well as maintaining current portfolio of vaccines on the market.
• Provide technical leadership and coaching to ensure timely and successful delivery of regulatory activities and compliance
• Manage and prioritize resources to deliver against timelines and objectives
• Lead team meetings related to the Quality, Safety, Effectiveness technical sections at regulatory agency meetings or support team members in this activity, as required.
• Initiate generation and review of appropriate policies, SOP’s, and guidance to ensure US and Canadian regulations are met throughout the organization, where applicable.
• Provide insight on the regulatory implications for product development, target label & registration through the participation in other teams (R&D; Global Marketing; Legal & M&Q etc.)
• Develop & maintain effective relationships with global regulatory authorities
• Influence and participate in industry associations.
• Working with R&D, enable the development and implementation of clinical trial submission plans – reviewing pertinent product / project related communications and publications
• Conduct licensing evaluations, as needed
• Represent Regulatory viewpoint and expertise on the development teams, governance meetings, including regulatory risk/benefit evaluations associated with proposed strategies
• In collaboration with Regional and/or local Regulatory Leader, assure efficient interactions with Health Authorities (HA)
• Develop global talent to sustain local and global competitiveness. This includes identifying and / or recruiting individuals with leadership & technical 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):

Education:

Master’s degree or higher in veterinary medicine, biologic, infectious diseases, immunology, or a related field

Experience:

• At least 10 years of relevant experience in the animal health industry, with direct Regulatory Affairs experience with Pharmaceutical; Biological & / or Nutritional products.
• Demonstrated experience in Regulatory Affairs; Regulatory Affiliate Operations, Quality and/or other relevant operational areas, but must include Regulatory leadership and / or registration experience.
• Understanding of global regulatory procedures available to study new veterinary biological products.
• Broad knowledge covering obtaining licenses in different geographies is preferable.
• Strong understanding of risk assessment and risk management fundamentals/tools
• Ability to make decisions when there is no clear right or wrong answer
• Demonstrated effective business partnering across the enterprise, function & with external stakeholders
• Strong interpersonal and communication skills, must understand how to influence and diplomatically challenge when needed
• Align resources with company objectives; facilitate accurate and timely project and budget forecasts
• Demonstrated courage in difficult situations.

Additional Preferences:

• Fluent in English
• Desired, Masters in Life Sciences or Management
• Knowledge of Continuous Improvement Six Sigma and Lean Principles
• Experience of working with novel regulatory pathways/mechanisms would be advantageous.
• Expected Travel : 10-25%

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