Director, Regulatory Affairs CMC (Business Process Lead)
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.
The Director, GRACS-CMC Business Process Lead will provide leadership, oversight and strategy in support of CMC Dossier preparation/maintenance and Health Registration Management (HRM) processes for the GRACS CMC organization. The Director will interface with a number of internal and external stakeholders to develop and oversee implementation of CMC regulatory procedures/processes for CMC Dossier Management and CMC Regulatory Information Management, making decisions that ensure process robustness and data integrity. This role will also serve as the primary point of contact to investigate and remediate gaps related to these CMC business processes.
The incumbent will provide regulatory oversight for CMC business process and platform changes through partnership and collaboration with system owners in GRACS and MMD. In addition the candidate is expected to partner with CMC stakeholders to develop, execute & provide oversight of regulatory CMC system/process initiatives of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges. The candidate is expected to anticipate how changes in the external regulatory environment will impact CMC business practices and to proactively recommend process improvements to minimize compliance risk. 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.
The Director will closely liaise with the Head of Regulatory Conformance to implement consistent CMC dossier and HRM procedures/processes that enable regulatory conformance. This will include simplification of current CMC procedures/processes and development of approaches that are intuitive and applied consistently across all CMC modalities. He/she will work collaboratively with global stakeholders and peers, to align on priorities and support the achievement of goals. This requires demonstrated critical thinking and effective problem solving skills with excellent interpersonal skills and the ability to prioritize multiple tasks. The Director may also support project team goals and organizational initiatives, on an as needed basis.
The Director must maintain a high level of professionalism, efficiency, and follow-through. 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. He/she must have a proven ability to communicate effectively in both a written and verbal format. He/she will responsible for proactive and timely communication of challenges and opportunities to management and to address them in a systematic and thoughtful manner. He/she will be expected to adequately represent department needs and positions in senior leadership forums. He/she must have the ability to work collaboratively in a team structure and must demonstrate a proven ability to work well under pressure.
Education Minimum Requirement:
- The candidate should possess a degree in science with at least 15 years of experience in pharmaceutical industry (10 years with an advanced degree).
- The ideal candidate will have strong experience in regulatory CMC and CMC dossier management processes/systems with demonstrated understanding of change control, CMC submission preparation and regulatory information management.
- The candidate should have exposure to CMC/regulatory activities across product development, registration and life-cycle management and CMC change management.
- He/She should have a thorough understanding of the external global regulatory environment to enable proactive identification of evolving regulatory expectations that may have an impact on regulatory conformance strategy.
- The candidate must be proficient in English; additional language skills are a plus.
Preferred Experience and Skills:
- Additional capability in project management, six sigma process & knowledge mapping, and change management 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.
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Visa sponsorship is not available for this position.
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Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck