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.
ASSOCIATE DIRECTOR GRACS CMC SMALL MOLECULE POST APPROVAL
West Point, PA Job #REG003920
Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances, and our organization's procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution. Primary responsibilities include, but are not limited to:
- Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. - Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. - Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. - Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. - Collaborate with our manufacturing division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. - Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. - Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. - Assess and communicate potential regulatory risks and propose mitigation strategies. - Deliver all regulatory milestones for assigned products across the product lifecycle - Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed
Education Minimum Requirement:
- B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. - At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields. - The candidate must be proficient in English; additional language skills are a plus.
Required Experience and Skills:
- Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. - 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 sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. - Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. - Demonstrated effective leadership, communication, interpersonal and negotiating skills. - Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
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 firstname.lastname@example.org.
To be considered for this position, please visit our career site at merck.com/careers, search jobs, create a profile and submit your resume for requisition # REG003920 to: