Associate Director, Drug Device (Regulatory Affairs) Center Of Excellence

Employer
Merck
Location
Upper Gwynedd, PA, US
Posted
April 17 2018
Organization Type
Pharma
Requisition ID: REG003694

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 assist in driving the overarching strategy for product specific devices or device constituents in partnership with the global regulatory lead and CMC scientists and various other functions.  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 establish 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 Associate director will drive cross functional collaboration across the enterprise by working closely with device development, commercial, clinical safety, Pharmacovigilance, manufacturing and IT areas to ensure successful execution of our product programs while maintaining regulatory and safety compliance.
 Primary Responsibilities include:
·       Assist in the interpretation of the global regulatory requirements for drug devices and combination products for new product development for initial registration and maintenance of the registration of established products.
·      Build and manage new processes for facilitating resources to support activities and key initiatives
·        Ensure close collaboration with cross functional teams to align on and incorporate regulatory requirements into strategies for devices and device constituents of combination products and digital solutions to ensure successful product registrations
·        Support the communication and assessment 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. 
·        Support the development of best practice guidance for regulatory deliverables for drug device and combination products to support the therapeutically aligned development teams.

Qualifications

RequiredB.S. in a biological science or a related field
Preferred:Advanced degree (MS, Ph.D.) 

Required Experience and Skills:

  • Knowledgeable in the global regulatory requirements and emerging landscape for Drugs, Devices, and Combination products for both new product development for initial registration and maintenance of registrations
  • At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
Preferred fields of study include Engineering, Regulatory Affairs, Quality or related sciences



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.

 

For more information about personal rights under Equal Employment Opportunity, visit:

 

            EEOC Poster

            EEOC GINA Supplement 





Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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