Director, Regulatory Affairs (CMC) - Small Molecule Post-Approval 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.
The Director, Global Regulatory Affairs and Clinical Safety (GRACS) -CMC will provide regulatory leadership, oversight and strategy in support of product/portfolio assignments for products in the post-approval lifecycle. Additionally, the Director may also manage a small number of individual contributors who are responsible for their own portfolio of products. He/she will be responsible for developing and overseeing implementation of regulatory strategies and making decisions that ensure the high quality of regulatory submissions. He/she will be expected to assess CMC post-approval changes to define regulatory requirements and develop CMC regulatory strategies that demonstrate sound regulatory insight, a balanced approach to risk and knowledge of the changing regulatory environment. He/she will work collaboratively with global stakeholders and peers, to align on priorities and support the achievement of product/portfolio goals. The Director may also support project team goals and organizational initiatives, on an as needed basis. He/she will be expected to adequately represent the department needs and positions in senior leadership forums. He/she will responsible for proactive and timely communication of challenges and opportunities to management and help address them in a systematic and thoughtful manner. He/she will be expected to embody the Merck values in their day-to-day activities and serve as an example by practicing them on a daily basis.
The candidate is expected to drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations. In addition he/she is expected to develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges. He/she will be responsible for assuring timely and accurate compilation and management of all necessary documentation for CMC submissions for license applications, supplements, establishment registrations and regulatory compliance submissions. He/she will work with team members to ensure quality, content and format of regulatory submissions to comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs. The incumbent will provide regulatory oversight for change control impact assessments, discrepancy management, regulatory conformance and inspection management systems. He/she may participate in internal Quality Review Boards, Change Review Boards and any other relevant governance committees and in external regulatory forums.
The candidate must maintain a high level of professionalism, efficiency, and follow-through as the leader of their teams. He/she will demonstrate critical thinking, effective problem solving, strong understanding of regulatory strategies, excellent interpersonal skills and the ability to prioritize multiple tasks. He/she must have a proven ability to communicate effectively in both a written and verbal format. He/she must have the ability to work collaboratively in a team structure and must demonstrate a proven ability to work well under pressure. The incumbent will be skilled to lead communications with regulatory agencies to facilitate review and approval of submissions.
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.
- The candidate should possess an advanced degree in science (PhD preferred) with at least 15 years or more of experience in pharmaceutical industry (10 years with an advanced degree).
- The ideal candidate will have strong experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
- The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data is required.
- He/she must have a depth of experience in defining global CMC strategy and must have collaboration and decision making capabilities to be successful in this role. .
- The candidate must have excellent interpersonal, communication and listening skills with a proven record of working with and influencing multi-disciplinary teams and external experts.
- The candidate must be proficient in English; additional language skills are a plus. The candidate may be required to travel on a periodic basis.
- A candidate with experience in CMC post-approval lifecycle management and strong API expertise is preferred
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:Dir, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
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: Philadelphia
Job Segment: Regulatory Affairs, Manager, Law, Pharmaceutical, Compliance, Legal, Management, Science