Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars
Elanco
13 hours ago
On-site
Lake County, IN
Corporate Functions
Your Role: Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars
Responsibilities:
- Guide, manage, and develop a high-performing global CMC group, ensuring effective resource allocation, performance management, and talent development.
- Provide expert CMC Regulatory advice on submission strategy and tactics for innovation and lifecycle submissions, especially for complex formulations and delivery systems.
- Represent regulatory CMC expertise on global development teams and governance meetings, providing insights on regulatory risk/benefit evaluations.
- Partner with global stakeholders across Elanco (Technical Development, Global Marketing, Manufacturing, Quality) to drive departmental strategy and efficiency.
- Manage timely submission of post-approval CMC documentation and guide interactions with global regulatory authorities (e.g., FDA-CVM, EMA, EPA) on CMC technical sections.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s Degree in a physical, chemical, or life sciences discipline.
- Experience: 10+ years of pharmaceutical or chemical regulatory experience; at least 5 years preparing and submitting CMC filings for global markets.
- Skills: Demonstrated leadership experience developing teams and in-depth knowledge of global regulatory CMC requirements.
What will give you a competitive edge (preferred qualifications):
- Experience with complex dosage forms (topicals, medicated collars, polymer-based delivery systems).
- Experience with the veterinary medicine and pesticide/biocide regulatory interface (e.g., EPA/FDA or ECHA/EMA).
- Advanced degree (MS, PhD, or PharmD).
- Knowledge of Quality by Design (QbD), Quality by Regulation (QbR), and GMP.
- Proven ability to influence internal and external stakeholders, including direct interaction with regulatory agencies.
Benefits and perks (highlights):
- 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
Additional information:
- Travel: 10–15%
- Location: Indianapolis (USA), Hook (UK), or Monheim (Germany) – On-Site work environment
Application instruction:
- If you think you might be a good fit but don’t meet every requirement, the company encourages you to apply.
Responsibilities:
- Guide, manage, and develop a high-performing global CMC group, ensuring effective resource allocation, performance management, and talent development.
- Provide expert CMC Regulatory advice on submission strategy and tactics for innovation and lifecycle submissions, especially for complex formulations and delivery systems.
- Represent regulatory CMC expertise on global development teams and governance meetings, providing insights on regulatory risk/benefit evaluations.
- Partner with global stakeholders across Elanco (Technical Development, Global Marketing, Manufacturing, Quality) to drive departmental strategy and efficiency.
- Manage timely submission of post-approval CMC documentation and guide interactions with global regulatory authorities (e.g., FDA-CVM, EMA, EPA) on CMC technical sections.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s Degree in a physical, chemical, or life sciences discipline.
- Experience: 10+ years of pharmaceutical or chemical regulatory experience; at least 5 years preparing and submitting CMC filings for global markets.
- Skills: Demonstrated leadership experience developing teams and in-depth knowledge of global regulatory CMC requirements.
What will give you a competitive edge (preferred qualifications):
- Experience with complex dosage forms (topicals, medicated collars, polymer-based delivery systems).
- Experience with the veterinary medicine and pesticide/biocide regulatory interface (e.g., EPA/FDA or ECHA/EMA).
- Advanced degree (MS, PhD, or PharmD).
- Knowledge of Quality by Design (QbD), Quality by Regulation (QbR), and GMP.
- Proven ability to influence internal and external stakeholders, including direct interaction with regulatory agencies.
Benefits and perks (highlights):
- 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
Additional information:
- Travel: 10–15%
- Location: Indianapolis (USA), Hook (UK), or Monheim (Germany) – On-Site work environment
Application instruction:
- If you think you might be a good fit but don’t meet every requirement, the company encourages you to apply.