Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, we’re driven by our vision of food and companionship enriching life – all to advance the health of animals, people and the planet. Learn more at www.elanco.com
This position is responsible for leadership of a North America Regulatory CMC (Chemistry, Manufacturing & Controls) team. This team is responsible for management of global CMC products with a focus on North American CMC Regulatory matters – develop regulatory strategy, oversee submission preparation and meet the reporting requirements for the registration/approval of new animal drug with global regulatory agencies. This position will help drive the Global CMC Regulatory strategy and serve as a member of the CMC Lead Team while also helping develop the NA Regulatory CMC team. This position also executes CMC regulatory functions necessary to provide supplements/variations, renewals, and annual reporting requirements for approved products, when needed.
Provide CMC Regulatory advice on submission strategy and tactics for execution of lifecycle submissions, with a diverse regulatory lens (i.e. USDA, CVM-FDA, MHRA etc.)
Develop local talent to sustain local & global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Work with the CMC Regulatory Lead Team to help set and drive the strategy and efficiency of the Global Regulatory CMC department
Work in partnership with global stakeholders across Elanco, including Global Regulatory Affairs, Pharmaceutical & Vaccine Development, Global Marketing and M&Q
Project manage timely submission of pre & post approval CMC documentation
Coordinate assembly and / or generate documentation of submission-ready components to support lifecycle submissions
Review and approve regulatory CMC documents to ensure compliance
Gain cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissions
Provide Regulatory Intelligence to support the operational and tactical regulatory CMC contribution and direction to Elanco product and project teams in support of products throughout the life cycle.
Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.
Perform any other duties or serve in such other capacity as may be determined by Company management.
10 years of pharmaceutical experience with at least 5 years in the preparation and submission of CMC filings (modules 3 and 2.3) for global markets.
Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Direct experience with the Center of Veterinary Medicine is preferred.
Demonstrated expertise & knowledge of the drug development processes and regulatory submissions
Understanding of current regulatory CMC requirements
Appreciation of the regulatory requirements applicable to a diverse global animal health portfolio
Sound technical knowledge of the manufacture of pharmaceuticals and appropriate understanding of all regulatory CMC disciplines
In-depth knowledge of US regulatory requirements pertaining to the manufacture of pharmaceutical drug substances and drug products.
A knowledge of regulations and submissions within other regions such as the EU, UK, Middle East & Africa, Latin America and Asia Pacific would be advantageous.
Demonstrated knowledge of regulatory lifecycle management processes – dossier preparation, submission and monitoring of post approval commitments.
Expert knowledge of agency requirements associated with filing submissions.
Direct experience interacting with regulatory agencies.
Knowledge of regulatory arena for FDA/EU desirable.
Skilled in risk-assessment methodologies, and project organization.
Experienced interpreting regulations and policies, and responding to associated questions.
Able to define problems, collect and review data, establish facts and draw valid conclusions.
Ability to evaluate metrics and trend data to drive robust continuous improvement plans.
Demonstrated ability to effectively communicate and collaborate across a matrix environment.
Fluent (written & verbal) in English
Additional language skills would be highly valued – but not essential
Desired, Masters or PhD in Physical, Chemical, or Life Sciences or Management
GMP knowledge and experience, including quality assurance would highly valued
Knowledge and understanding of QbD and QbR
Personal Considerations: Domestic and international travel required
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