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Executive Director, Regulatory Affairs

Upper Gwynedd, PA, USA | Merck

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Regulatory Affairs
  • Experience:
    10-12 years
Job Description:
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Description

 

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, GRACS (Global Regulatory Affairs and Clinical Safety) CMC manages a team of CMC product and/or team leaders supporting a large portfolio of global products. The products may include small molecules, biologics, and/or vaccines and may be at any stage of the products’ life cycle from development to post-marketing. The Executive Director plays a critical role in negotiating and achieving alignment in partnership with other functional areas in GRACS and within CMC, with Merck Research Labs, Merck Manufacturing Division and Global Human Health to ensure alignment on prioritization and CMC regulatory strategies for products and projects within their assigned portfolio while maintaining submissions in a compliant manner. The Executive Director is accountable for ensuring a high rigor level of CMC regulatory strategy as well as delivery of high quality CMC submissions for all products within their assigned portfolio. The Executive Director, as a Senior member of the GRACS CMC Organization, will also manage significant cross-modality projects as an extension of the overall GRACS CMC Leadership Team. 


Responsibilities:


Proactively identify, investigate, and resolve complex regulatory challenges with potential impact to critical priorities and company objectives. Identify and effectively communicate CMC regulatory strategy, risk, mitigation and overall plan to other functions within GRACS, Merck Research Labs, Merck Manufacturing Division management team, and escalate to executive management, as needed.

Deliver business objectives through critical review and timely delivery of robust and compliant regulatory impact assessments, regulatory strategies, and high quality submissions for the assigned product portfolio. This includes critical review of key development plans to ensure a high level of regulatory rigor and compliance with global guidance during product development as well as planning for post-approval changes.

Effectively negotiate priorities in partnership with stakeholders to enable successful resource planning and flexible allocation to ensure success on prioritized business objectives, utilizing applicable resource models to project future resource requirements and flexible sourcing options to meet the profit plan.

Consider and apply appropriately balanced perspectives (regulatory, business, technical, global, etc.) when making decisions and generating solutions. Influence and drive consensus across divisions to reach rapid, disciplined decision and develop plans to execute.

Manage, coach, and mentor CMC staff to manage performance and advance personal and professional development goals. Identify key talent and provide development opportunities that enable growth and retain talent.

Represent GRACS CMC on key executive level meetings and leadership forums, as a delegate for the CMC Leadership Team member, as required. Actively engage as a Leadership Team member within the assigned CMC department.

Establish strong cross-functional and divisional relationships with key stakeholders, customers and external organizations.

Evaluate key business challenges within assigned portfolio and collaborate with team members to direct the development of innovative and compliant solutions.

Ensure adherence to regulatory process execution to deliver high quality regulatory CMC submissions, correspondence and Health Authority interactions.

Ensure all communications are timely, clear and concise, impactful, and at an appropriate level of detail for the intended audience. Communications to Senior and Executive Management will be expected for products and projects within the assigned scope.


 

Qualifications

 

Education:


Required:Bachelor’s Degree in pharmacy, chemistry, engineering or related-scientific discipline, with a minimum of (10) years’ experience in the Pharmaceutical Industry (OR) an advanced degree with a minimum of (5) years’ experience in the Pharmaceutical Industry.

Preferred:Advanced degree with a minimum of (5) years’ experience in the Pharmaceutical Industry.

Required: 


Minimum of (5) years’ experience in CMC Regulatory with progressive experience in leading global programs and teams.

Minimum of (5) years People Management / Project Leadership experience with proven track record of managing and developing talent. 

Demonstrated ability to anticipate and effectively influence within and across divisions and in the external business and regulatory environment to identify potential challenges impacting the business and proactively recommend approaches to minimize regulatory risk

Recognized as a leader with broad expertise in CMC regulatory strategy and dossier development and life-cycle management.

Experience leading organizational or process related change to drive effective execution and continuous improvement.

Demonstrated ability to innovate with regulatory strategies and business processes.

Demonstrated ability to recruit, train and develop staff, to motivate others and drive continuous improvement.

Flexibility to operate in a matrix-managed environment and to support staff in that same environment


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