Director, Regulatory Affairs, CMC (Biologics) Job
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 Director is responsible for implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for Merck's biologics product franchises in accordance with domestic and international regulations and guidances, and is responsible for the preparation and submission of CMC sections for commercial and new biologics products. The Associate Director will assist in the development and the implementation of internal regulatory strategies, provides mentoring and coaching to Sr. Specialist/Specialist in support of their assigned projects.
The Director responsibilities include but are not limited to:
As an individual contributor uses facilitative leadership skills to lead team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemistry, manufacturing and control (CMC) documentation for worldwide registration.
Requires continual correspondence and interaction with regulatory agencies and other scientists to support either new or in-line product filings worldwide.
Maintain working knowledge of current governmental and worldwide requirements for initial registration, re-registration and post-approval changes.
Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems.
Ensures consistency in practices, champions best practices and promotes operational excellence
Leads others in the biopharmaceutical industry and drives regulators to reduce the regulatory burden of bringing new medicines to market and making post approval improvements in CMC Biologics
Uses breadth and depth of regulatory, scientific, and technical knowledge to inform strategy development and execution by manufacturing, technical and development teams and to ensure quality of all regulatory interactions and submissions
Supports talent development within team and within department
Participation in early and late development programs, as well as departmental and cross-functional efforts to improve CMC content or processes may also be required, as needed.
Occasional travel to manufacturing sites may be required.
Required: B.S. in biological sciences, biochemical engineering, or a related discipline.
Preferred: Advanced degree with a concentration in Microbiology, Virology, Molecular Biology, Engineering or Biochemistry
A minimum 10 years biologics experience
Industrial/regulatory experience in biologics research, development and/or manufacturing
Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience
Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
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 flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
At least ten (10) years of relevant experience in support of biologics
Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry
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 an accommodation for the application process please email us at firstname.lastname@example.org.
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Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck