Merck Director, Regulatory Affairs-CMC 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 Executive Director, the Director is responsible for implementing CMC regulatory strategies for Merck's vaccine products in accordance with global regulations and guidances, and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products.

Primary responsibilities include, but are not limited to:

Regulatory Responsibilities:

• The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.

• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity.

• Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.

• Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, 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 applies this understanding to the benefit of the company to ensure the approval and continued market supply of Merck vaccine products worldwide.

• Conduct all activities with an unwavering focus on compliance.

Technical Skills:

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are 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.

Leadership Skills:

• 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.

Education Minimum Requirement:

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, or Biochemistry.

Required Experience and Skills**:

• At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields.

• The candidate must be proficient in English; additional language skills are a plus.

• The candidate may be required to travel on a periodic basis.

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

Other Locations: NA-US-NJ-Kenilworth

Title: Director, Regulatory Affairs-CMC

Primary Location: NA-US-PA-West Point

Requisition ID: REG004200