Associate Director, Regulatory Affairs-CMC, CMC Biologics Job - United States
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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 guidances, and is responsible for the preparation and submission of CMC sections for commercial and new biologics products. The Associate Director will assists in the development and the implementation of internal regulatory strategies, provides mentoring and coaching to Sr Specialist/Specialist in support of their assigned projects.
Primary responsibilities include, but are not limited to:
- Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment); new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide.
- Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team.
- Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management.
- 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.
- Demonstrates a strong 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.
- Generates innovative solutions to complex regulatory problems and effectively works with and communicates to key stakeholders.
- Regulatory Responsibilities:
- Maintain working knowledge of the domestic and international regulations that govern the investigational product development, licensure of biologics, and post-approval changes
- Provides regulatory input and support during time of governmental inspections of the site.
- 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.
- 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 Seven (7) years of experience in support of biologics
- Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at email@example.com.
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Job: Regulatory Affairs - CMC
Job Title:Assoc. Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Kenilworth
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Manager, Regulatory Affairs, Engineer, Law, Biochemistry, Legal, Management, Engineering, Science