Director, Regulatory Affairs CMC

Requisition ID: REG003103 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 will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for post approval biologics.  This includes preparation of applicable sections of post approval supplements (Variations), Agency Background Packages, and responses to Agency questions for global markets. The primary focus of the position is providing direction to team members responsible for developing and executing implementation of regulatory strategies, and making decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes assessment for strategic projects and for routine changes, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment. This individual will be responsible to build the post approval biologics CMC by hiring, mentoring and coaching team members. In conjunction with peers, the individual will be involved in development of tools that enable the optimization of the CMC regulatory function. In addition to routine administrative tasks, this individual will also be involved in assessment and development of talent within the organization.   Responsibilities: Accountable for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.  Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges.  Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations. Embody the Merck Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.  Continuously evaluate and develop talent within the team and prepare a succession plan. Use recognition and rewards to promote team and organizational collaboration.  Hold employees accountable for execution of departmental policies and procedures. Flexibly manage and allocate resources within area to support execution and delivery of prioritized work to meet business commitments. Actively sponsor employees who lead and participate in Merck initiatives.  Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization.  Represent the department's needs and positions in senior leadership forums. Qualifications Education Requirement:   Degree in pharmacy, chemistry, engineering or a related discipline; post-graduate degreepreferred..  Required Experience: Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree.  Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle. Minimum 3 years managing people.  Preferred Experience:     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, and quality assurance) and experience managing a team of Regulatory CMC professionals.  A candidate with strong experience in Biologics pre/post approval expertise is highly preferred.  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.  He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.  The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts. The candidate must have demonstrated experience in building, rewarding and retaining key talent. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.  The candidate must be proficient in English; additional language skills are a plus.   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 staffingaadar@merck.com.    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:               EEOC Poster             EEOC GINA Supplement  Job: Regulatory Affairs - CMC Other Locations: Kenilworth, NJ, US Employee Status: Regular Travel: Yes, 10 % of the Time Number of Openings: 1 Shift (if applicable): 1st Hazardous Materials: Company Trade Name: Merck
Salary Range: NA
Minimum Qualification
15+ years

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