Director, Regulatory Affairs - Drug Device Job

Director, Regulatory Affairs - Drug Device-REG002539

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Under the general direction of the Executive Director, Regulatory Affairs-US and Global Functions, Drug Device Center of Excellence the incumbent will drive the development of product specific devices or device constituent regulatory strategies in partnership with the global regulatory lead and CMC scientists. The incumbent will partner with the Clinical Safety and Risk Management physicians and Pharmacovigilance group device subject matter experts (SME) to ensure the clinical aspects needed to support the filing are planned and executed to support registration and/or maintenance of registrations.

The incumbent will provide subject matter expertise to established processes and develop internal guidance for Global Regulatory Affairs and Clinical Safety (GRACS) that enables timely accurate advice to Global Regulatory Teams to ensure adherence to the evolving drug device and combination product regulations globally. The director will drive cross functional collaboration across the enterprise by working closely with device development, commercial and manufacturing areas to ensure successful execution of our product programs while maintaining regulatory and safety compliance.


Primary Responsibilities Include:

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Drive the interpretation of the global regulatory requirements for drug devices and combination products for both new product development for initial registration and maintenance of the registration of established products.

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Ensure close collaborate with the device development organization to align on and incorporate regulatory requirements into development strategy for devices and device constituent of combination products to ensure successful product registrations

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Lead the communication of the emerging regulatory landscape and drive cross functional implementation of existing and new requirements across the affected GRACS functional areas for devices and combination products. While enabling close collaboration between the device SME network within GRACs functions.

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Ensuring close collaborate with manufacturing colleagues involved in drug/device activities to support regulatory compliance and successful product registrations

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Work closely with regulatory policy to impact evolving requirements by actively engaging externally in the drug/device area.

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Support the development of best practice guidance for regulatory deliverables for drug device and combination products to support the therapeutically aligned development teams.

Qualifications

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M.D. or PhD with 3 to 5 years relevant drug and/or device development experience preferably with 3 years in device regulatory or M.S. or B.S. with 7 to 10 years relevant drug and/or device development experience a majority of which was in device or combination product development with minimum 5 years in device regulatory

Required Skills

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Expertise in the global regulatory requirements and emerging landscape for Drug Devices and Combination products for both new product development for initial registration and maintenance of registrations

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Excellent interpersonal, communication and negotiation skills are required.

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Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.

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Demonstrated leadership attributes; experience leading high performing cross disciplinary teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

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 staffingaadar@merck.com.

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Job: Regulatory Affairs Generic

Job Title:Sr. Prin. Scientist, Regulatory Affairs

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck