Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars
Elanco
13 hours ago
On-site
Indianapolis, IN
Corporate Functions
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 for complex formulations and delivery systems.
- Represent regulatory CMC expertise on global development teams and governance meetings, providing critical insights on regulatory risk/benefit evaluations.
- Partner with global stakeholders across Elanco (Technical Development, Global Marketing, Manufacturing, and 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.
Minimum Qualifications:
- Bachelor’s Degree in a physical, chemical, or life sciences discipline.
- 10+ years of pharmaceutical or chemical regulatory experience; 5+ years preparing and submitting CMC filings for global markets.
- Demonstrated leadership ability and in-depth knowledge of global regulatory CMC requirements.
Preferred Qualifications:
- Experience with complex dosage forms (topicals, medicated collars, polymer-based delivery systems).
- Experience navigating veterinary medicine and pesticide/biocide regulatory interfaces (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/external stakeholders, including direct regulatory agency interactions.
Benefits and Perks:
- 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; flexible work arrangements; up to 6% 401K matching.
Additional Information:
- Travel: 10–15%; On-site locations: Indianapolis (USA), Hook (UK), or Monheim (Germany).
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 for complex formulations and delivery systems.
- Represent regulatory CMC expertise on global development teams and governance meetings, providing critical insights on regulatory risk/benefit evaluations.
- Partner with global stakeholders across Elanco (Technical Development, Global Marketing, Manufacturing, and 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.
Minimum Qualifications:
- Bachelor’s Degree in a physical, chemical, or life sciences discipline.
- 10+ years of pharmaceutical or chemical regulatory experience; 5+ years preparing and submitting CMC filings for global markets.
- Demonstrated leadership ability and in-depth knowledge of global regulatory CMC requirements.
Preferred Qualifications:
- Experience with complex dosage forms (topicals, medicated collars, polymer-based delivery systems).
- Experience navigating veterinary medicine and pesticide/biocide regulatory interfaces (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/external stakeholders, including direct regulatory agency interactions.
Benefits and Perks:
- 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; flexible work arrangements; up to 6% 401K matching.
Additional Information:
- Travel: 10–15%; On-site locations: Indianapolis (USA), Hook (UK), or Monheim (Germany).