Associate Director, Regulatory Affairs-CMC (Biologics)
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.
Under direction from Director/Executive Director, the Associate 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 guidance, 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 Associate Director responsibilities include but are not limited to:
- Participation in the authorization process to prioritize submissions.
- In depth knowledge of global CMC guidelines regarding post approval changes.
- Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
- Development and execution of detailed, global regulatory strategies for submission and approval of post approval change documentation according to defined timelines.
- Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
- Lead authoring of clear, concise and effective global post approval submissions according to defined timelines.
- Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve project issues through collaboration with the team and escalation to the CMC leadership team as appropriate.
- 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 a biological science or a related field
- Preferred: Advanced degree (MS, Ph.D.)
- A minimum 5 years of 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.
- 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
Preferred Experience and Skills:
- At least seven (7) years of experience in support of biologics
- Experience with post approval changes in Biologics or Vaccines
- 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