Associate Director, Regulatory Affairs Pharmaceuticals
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
As Manager in the US Regulatory Affairs Pharmaceuticals team, the Associate Director is responsible, but is not limited to the following duties:
- Prioritize and manage FDA product and other regulatory-related submissions adhering to timelines, liaising regularly with FDA, where appropriate.
- Participate alongside the Director of US RA in the defining of and carrying through with the defined regulatory strategy.
- Disseminate relevant FDA regulatory guidance and policy to interdepartmental teams.
- Manage Advertisement and Promotion Regulatory Affairs review for new products and support team specialists in review of existing products.
- Participate in international projects as part of Global Regulatory Affairs in Merck Animal Health.
Education Minimum Requirement:
- Master's degree required
- Doctorate-level degree preferred (either Doctorate of Veterinary Medicine (DVM) or PhD in a relevant health-related field).
Required Experience and Skills:
- Minimum of 5 years of Regulatory Affairs experience in pharmaceutical industry or equivalent (e.g., governmental agency)
- Minimum of 3 years direct experience working for or with the FDA Center of Veterinary Medicines (CVM) on the development and registration of veterinary animal health products.
- Excellent time and project management skills.
Preferred Experience and Skills:
- Excellent people, communication and leadership skills for interaction with cross-departmental teams.
- Knowledge and understanding of the animal health sector with a consistent analytical approach to problem-solving.
- EPA (Environmental Protection Agency) experience and/or knowledge of vaccine development are considered a plus.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need an accommodation for the application process please email us at email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
For more information about personal rights under Equal Employment Opportunity, visit:
Job: Regulatory Affairs Generic
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck