Associate Director, Regulatory Affairs Site CMC Conformance
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 West Point manufacturing site. The establishment of site CMC is a key component of Merck’s strategy to build effective linkage of the CMC Regulatory Affairs 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.
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.
–Acts as a point of escalation for regulatory compliance or related issues that may arise at the manufacturing site and a Subject Matter Expert in the management and resolution of any such issues.
–Holds HR and line management responsibilities for the Site CMC Senior Regulatory Specialist supporting the West Point manufacturing site.
–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 5 years of experience in the pharmaceutical industry in a regulatory, compliance, technical or quality role. The candidate must have a minimum of 3 years’ experience 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 FDAOffice of Vaccines and other global vaccine regulatory requirements is highly desired.
· The candidate must havea good understanding of and experience working with busy commercialmanufacturing organization.
· He/she must be able toeffectively manage the competing demands of site and corporate stakeholders.
· He/she will demonstrateeffective problem solving, understanding of regulatory strategies, excellentinterpersonal skills, detail oriented, and able to prioritize multiple tasks.
· Must have a provenability to communicate effectively in both a written and verbal format.
· Ability to influence andwork both independently and collaboratively in a team structure.
· Proven ability to workwell 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.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org.
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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:
Shift (if applicable):
Company Trade Name: Merck