Associate Director, Regulatory Affairs, CMC - Elkton, VA
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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The candidate will be part of Merck’s corporate Regulatory CMC organization and will act as the Regulatory CMC Lead within the Elkton manufacturing site. The establishment of site CMC is a key component of Merck’s strategy to build effective linkage of the CMC RA organization with the Merck Manufacturing Division (MMD).
The site CMC role will support the conformance of Merck products with the approved Marketing Authorizations and will support regulatory submission activities associated with the site. The CMC Associate Director will act as the key CMC liaison with the Site leadership.Qualifications
- Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences etc.)
- At least 5 years of experience in the pharmaceutical industry in a regulatory, compliance, quality or technical role.
- At least 3 years experience in Regulatory CMC for vaccines or biotechnology, or significant technical and scientific background and expertise in Vaccines with exposure to Regulatory CMC projects and Regulatory Agencies.
- Some knowledge of FDA Office of Vaccines and other global vaccine regulatory requirements is highly desired
- The candidate must have a good understanding of and experience working with a busy commercial manufacturing organization. He / she must be able to effectively manage the competing demands of site and corporate stakeholders.
- He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Must have a proven ability to communicate effectively in both a written and verbal format.
- Ability to influence and work both independently and collaboratively in a team structure.
- Proven ability to work well under pressure.
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.
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Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck