Sr. Specialist, Regulatory Affairs, Site CMC
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 support CMC Conformance within the West Point manufacturing site. 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, Regulatory Affairs 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.
– 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.
–Coordinates submission component authoring (mainly for post-approval CMC changes) with site SMEs and CMC product leads.
–Supports product teams to coordinate responses to Health Authority (HA) questions on submissions impacting manufacturing sites.
–Sources and provides technical data and reports, ancillary submission documents to support regulatory submissions and HA questions.
–Participates in major project teams where there will be significant regulatory impact, e.g. product transfer teams.
–Ensures that HA commitments are captured in site commitment tracking and are fulfilled.
–Supports HA notifiable events and investigations.
–Supports HA inspections to the manufacturing site.
–Supports Drug Master File, Site Master File authoring / updates.Qualifications
Education Minimum Requirement:
The candidate must possess a relevant Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences, etc.).
Required Experience and Skills:
A minimum of 3 years of experience in the pharmaceutical industry in a regulatory, compliance, technical or quality role. The candidate must have a some experience (1-2 years) in CMC Regulatory Affairs for vaccines or biotechnology.
•Exceptional candidates without direct CMC experience will be considered where they possess a significant Vaccines technical and scientific background and they have prior experience of significant engagement with Regulatory CMC projects and Regulatory Agencies
Preferred Experience and Skills:
•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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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.
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Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck