Merck Associate Director GRACS CMC Small Molecule Post Approval in West Point, Pennsylvania
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.
Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances, and our organization's procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution. Primary responsibilities include, but are not limited to:
Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
Collaborate with our manufacturing division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle
Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed
Education Minimum Requirement:
B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
The candidate must be proficient in English; additional language skills are a plus.
Required Experience and Skills:
Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
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 email@example.com .
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
Other Locations: NA-US-NJ-Rahway
Title: Associate Director GRACS CMC Small Molecule Post Approval
Primary Location: NA-US-PA-West Point
Requisition ID: REG003920