Director, Global Regulatory Affairs - Drug Device COE Job

3 days left

Recruiter
Location
Upper Gwynedd PA
Posted
Jul 31, 2017
Closes
Aug 21, 2017
Organization Type
Corporate
Director, Global Regulatory Affairs - Drug Device COE-REG003068

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.

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 PV group device SMEs 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:

- 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.

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

- 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.

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

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

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

Qualifications

Education:

- M.D. or PhD with minimum of 3 years relevant drug and/or device development experience with a minimum 3 years in device regulatory or M.S. or B.S. with a minimum of 7 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

- 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

Required Skills:

- Excellent interpersonal, communication and negotiation skills are required.

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

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

Minimum Requirement:

- M.D. or PhD with minimum of 3 years relevant drug and/or device development experience preferably with a minimum 3 years in device regulatory or M.S. or B.S. with minimum of 7 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 Experience:

- 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

- Excellent interpersonal, communication and negotiation skills are required.

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

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

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.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


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