Director, Regulatory Affairs Biologics CMC (Keytruda) Job

Director, Regulatory Affairs Biologics CMC (Keytruda)-REG002392


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.

- 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



- The candidate must possess an advanced degree in science (Ph.D. preferred)


- At least 10 years biologics experience within the pharmaceutical industry.

- The ideal candidate will have strong experience in Regulatory CMC, as well as development, manufacturing or quality assurance experience .

- Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience in a leadership role. 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. The candidate is expected to develop and possess an expert knowledge of Industry Association Whitepapers, HA regulations & guidance documents. He/she is expected to utilize the expert knowledge and reputation to influence the content of new Industry Association Whitepapers, HA guidance & regulations.

- 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.

- The candidate must have a proven record of working with and influencing multi-disciplinary teams and external experts and must have demonstrated leadership, communication, problem solving and decision making skills. The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis.


- At least 10 years of relevant experience in support of biologics

- Preferred fields of study include Biochemistry, Molecular Biology, Engineering, Microbiology, or Virology

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

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Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job: Regulatory Affairs - CMC

Job Title:Dir, Regulatory Affairs-CMC

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck