Requisition ID: REG004394
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.
• Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in the pre-approval space.
• The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the development, communication, 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, original BLA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Support new technology development within Merck.
• 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 Biologics products worldwide.
• Conduct all activities with an unwavering focus on compliance.
• May need to manage or mentor junior team members.
• 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.
• 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 CMC development; manufacturing, testing, or licensure of biological 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: West Point, PA, US
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): N/A
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark