Executive Director, Regulatory Conformance

Requisition ID: REG004009
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 Executive Director, Global Regulatory Affairs & Clinical Safety (GRACS)-CMC, Site CMC & Conformance is accountable for management of the global Site CMC Conformance organization and leading the site-based CMC resources and programs at 16+ global manufacturing sites. This includes providing support for site change control development/assessment, representing GRACS CMC on Site Change Review Boards and providing regulatory CMC input into inquiries. The Executive Director, GRACS CMC Conformance provides leadership and oversight to administer global CMC Conformance programs that maintain the accuracy of global CMC dossiers.
The Executive Director is accountable for monitoring the current state of CMC regulatory systems/processes and working with manufacturing sites to deliver a sustainable level of regulatory conformance. The Executive Director, GRACS CMC Conformance is accountable for working cross-functionally across all modalities (biotherapeutics, pharmaceuticals and vaccines) in GRACS CMC and with manufacturing site personnel to facilitate the regulatory assessment of change control information and recommend regulatory actions that will enable sustained conformance of regulatory information.
Collaborate and build relationships with stakeholders at manufacturing sites and oversee Site CMC input to change control development/assessment, Site Change Review Boards and CMC-related inquiries.
Develop creative and imaginative approaches to resolve problems, flexibly allocate resources and respond to changing priorities or unexpected events.
Proactively identify and solve the most complex problems that may impact the management and direction of regulatory conformance practices.
Collaborate with global stakeholders across multiple disciplines and multiple organizations to develop, adapt and execute regulatory conformance strategy.
Manage project definition and resource requirements for optimization projects, as required.
Represent GRACS CMC in senior leadership forums to report on regulatory conformance status, potential risks, business impact and mitigation strategies in a clear, concise and balanced manner.
Education Requirement:
Degree in pharmacy, chemistry, engineering or a related scientific discipline; post-graduate degree preferred.
Minimum 20 years pharmaceutical industry experience; 15 years with an advanced degree.
Minimum 10 years working in Regulatory CMC, including experience with CMC change management processes and leadership of regulatory conformance programs.
Minimum of 5 years managing people.
The candidate must be proficient in English; additional language skills are a plus.
The candidate will be required to travel on a periodic basis
Recognized as a CMC expert with broad expertise in CMC/regulatory and change management activities across product development, registration and life-cycle management, as well experience in product development, manufacturing or quality control/quality assurance.
Demonstrated ability to anticipate and influence internal/external business and regulatory environment to identify potential changes impacting business practices and proactively recommend process improvements to minimize compliance risk
Thorough understanding of external business and global regulatory environment to enable proactive identification of evolving regulatory expectations that may have an impact on the company and regulatory conformance strategy.
Detail oriented leader with strong leadership/people management skills and exceptional interpersonal, collaboration and communication skills.
Demonstrated ability to interpret and apply diverse regulatory requirements to development of compliant regulatory processes that effectively balance regulatory expectations with business needs.
Experience in leading Health Authority interactions and communication strategy development.
Proven track record in working and influencing multi-disciplinary teams with demonstrated leadership, communication, innovative problem solving and rapid, disciplined decision making, critical thinking capabilities, and ability to work well under pressure.
Exceptional interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.
Demonstrated experience in building, rewarding, developing and retaining key talent.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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.
Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of it's manifestations.
Job: Regulatory Affairs - CMC
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck
Nearest Major Market: Philadelphia

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