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.
DIRECTOR, REGULATORY AFFAIRS, CMC
West Point, PA Job #REG003106
The Director, GRACS-CMC will provide regulatory leadership, oversight and strategy in support of product/portfolio assignments for biological 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 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 biopharmaceutical 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. - A candidate with experience in CMC post-approval lifecycle management and strong API expertise is preferred. - 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.
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