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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.
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 a specialist of the US Regulatory Affairs Pharmaceuticals team, the Specialist is responsible, but is not limited to the following duties:
Prepare DERs (drug experience reports) for FDA on existing products
Review product labeling for existing and, where necessary, new products.
Review and submit to FDA A & P (advertisement and promotion) material.
Aid in the preparation of Free Sales Certificates for US manufactured products as part of the Global RA (regulatory affairs) responsibilities
Prepare and submit State license fees for new and existing products.
Education Minimum Requirement:
Required Experience and Skills:
Minimum of 3 years of Regulatory Affairs experience, preferablyin the animal health industry
Working knowledge of FDA or equivalent requirements and regulations relating to manufacturing of veterinary medicinal products
Preferred Experience and Skills:
Some added familiarity with EPA (Environmental Protection Agency) procedures would be appreciated.
Excellent time and project management skills.
Excellent people, communication and leadership skills for involvement with cross-departmental teams.
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 firstname.lastname@example.org.
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.