Requisition ID: REG004096
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 Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we're a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
The Senior Specialist, Regulatory Affairs-Site Chemistry Manufacturing Controls will be part of Merck's corporate Regulatory CMC organization and will support Site CMC and Conformance for the Las Piedras, Xochimilco and Campinas manufacturing sites. The establishment of site CMC Conformance is a key component of Merck's strategy to build effective linkage of the CMC RA organization with the Merck Manufacturing Division (MMD).
Reporting to the Associate Director, Site CMC Conformance, the Senior Regulatory Specialist role will support the conformance of Merck products with the approved Marketing Authorizations and will support regulatory submission activities associated with the site.
Core function - manage the interface between the Manufacturing Site and Regulatory CMC to maintain product regulatory conformance. Specific responsibilities include:
- Ensuring that the information included in regulatory submissions/filings is aligned to plant information and supports future compliance and maintenance.
- Ensuring that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are managed & processed efficiently through to last market approval and implementation.
- Ensuring that regulatory information is correctly maintained, updated and interpreted, using Merck Regulatory Information systems and tools.
- Working with site Quality, Technical and Supply chain functions to ensure that product is released in accordance with the relevant Global Marketing Authorizations.
This position is based in Merck Las Piedras, Puerto Rico. Does not include relocation assistance.
- Bachelor's degree or higher in Science (e.g. Pharmacy, Chemistry, Biotechnology, Microbiology, Biomedical Sciences).
- Three (3) years or more of experience in the pharmaceutical industry in a regulatory, compliance, technical or quality role.
- One (1) or more years of experience in CMC Regulatory Affairs role, ideally gained in a manufacturing environment or regulatory agency.
- 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, in English and Spanish.
- Ability to influence and work both independently and collaboratively in a team structure.
- Willing to travel up to 5% of the time.
Our 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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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name: Merck