Director, Regulatory Affairs CMC – Small Molecule Post-Approval
Merck & Co., Inc.Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is aglobal health care leader with a diversified portfolio of prescriptionmedicines, vaccines and animal health products. The difference betweenpotential and achievement lies in the spark that fuels innovation andinventiveness; this is the space where Merck has codified its legacy forover a century. Merck’s success is backed by ethical integrity, forwardmomentum, and an inspiring mission to achieve new milestones in globalhealthcare.
Merck is on a quest forcures and is committed to being the world’s premier, most research-intensivebiopharmaceutical company. Today, we’re doubling down on this goal. MerckResearch Laboratories is a true scientific research facility of tomorrow, and willtake Merck’s leading discovery capabilities and world-class small molecule andbiologics R&D expertise to create breakthrough science that radicallychanges the way we approach serious diseases.
The Director, GRACS-CMCwill provide regulatory leadership, oversight and strategy in support ofproduct/portfolio assignments for products in the post-approvallifecycle. Additionally, the Director may also manage a small numberof individual contributors who are responsible for their own portfolio ofproducts. He/she will be responsible for developing and overseeingimplementation of regulatory strategies and making decisions that ensure thehigh quality of regulatory submissions. He/she will be expected to assess CMCpost-approval changes to define regulatory requirements and develop CMCregulatory strategies that demonstrate sound regulatory insight, a balancedapproach to risk and knowledge of the changing regulatory environment. He/shewill work collaboratively with global stakeholders and peers, to align onpriorities and support the achievement of product/portfolio goals. The Directormay also support project team goals and organizational initiatives, on an asneeded basis. He/she will be expected to adequately represent the departmentneeds and positions in senior leadership forums. He/she will responsible forproactive and timely communication of challenges and opportunities tomanagement and help address them in a systematic and thoughtful manner. He/shewill be expected to embody the Merck values in their day-to-day activities andserve as an example by practicing them on a daily basis.
The candidate isexpected to drive the application of regulatory strategies and concepts acrossmultiple disciplines and multiple organizations. In addition he/she is expectedto develop, execute & provide oversight of regulatory initiatives &strategies of significant complexity and apply exceptional ingenuity to solveproblems and mitigate potential regulatory challenges. He/she will beresponsible for assuring timely and accurate compilation and management of allnecessary documentation for CMC submissions for license applications,supplements, establishment registrations and regulatory compliancesubmissions. He/she will work with team members to ensure quality, contentand format of regulatory submissions to comply with applicable regulations andguidelines governing the development, licensure and marketing of drugs. Theincumbent will provide regulatory oversight for change control impactassessments, discrepancy management, regulatory conformance andinspection management systems. He/she may participate in internal QualityReview Boards, Change Review Boards and any other relevant governancecommittees and in external regulatory forums.The candidate must maintaina high level of professionalism, efficiency, and follow-through as the leaderof their teams. He/she will demonstrate critical thinking, effective problemsolving, strong understanding of regulatory strategies, excellent interpersonalskills and the ability to prioritize multiple tasks. He/she must have a provenability to communicate effectively in both a written and verbal format. He/shemust have the ability to work collaboratively in a team structure and mustdemonstrate a proven ability to work well under pressure. The incumbentwill be skilled to lead communications with regulatory agencies to facilitatereview and approval of submissions.
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.
- 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.
- A candidate with experience in CMC post-approval lifecycle management and strong API expertise is preferred
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.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck