Associate Director, Regulatory Affairs Pharmaceuticals Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Merck Animal Health is a global, research-driven company that develops, manufactures and markets a broad range of veterinary medicines and services. We offer one of the industry’s most innovative portfolios, spanning products for the prevention, treatment and control of disease in all major farm and companion animal species.
As (Submission) Manager in the US Regulatory Affairs Pharmaceuticals team, the Associate Director is responsible, but is not limited to the following
- Prioritize and manage FDA product and other regulatory-related submissions adhering to timelines, liaising regularly with FDA, where appropriate.
- Support the Director of US RA in defining and carrying through 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, where necessary, collaborate with team specialists on review of existing products as scientific expert.
- Participate in international projects, where necessary, as part of Global Regulatory Affairs in Merck Animal Health.
Education Minimum Requirement:
- Doctorate-level degree (either Doctorate of Veterinary Medicine, DVM or PhD in a relevant health-related field).
Required Experience and Skills:
- Minimum of 5-7 years of Regulatory Affairs experience, or equivalent, in pharmaceutical industry or equivalent (e.g., governmental agency).
Preferred Experience and Skills:
- Knowledge and understanding of the animal health sector with consistent incorporation of a science-based approach to problem-solving.
- Strong working knowledge of FDA requirements and regulations relating to the development of pharmaceutical and associated animal health products.
- Excellent people, communication and leadership skills for involvement with cross-departmental teams with preference for candidates who have experienced a multi-cultural global work environment.
- Excellent time and project management skills.
- EPA (Environmental Protection Agency) experience is considered a plus.
- Knowledge in vaccine development would be considered a plus.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Regulatory Affairs Generic
Job Title:Assoc. Dir, Regulatory Affairs
Primary Location: NA-US-NJ-Madison
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: New Jersey
Job Segment: Regulatory Affairs, Manager, Law, Compliance, Pharmaceutical, Legal, Management, Science