Director, Global Regulatory Affairs Lead: Oncology Job

Director, Global Regulatory Affairs Lead: Oncology-REG002503

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.


The Director, Liaison, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Oncology, Immunology and Devices therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, global point of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more Merck investigational and marketed drugs/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to the GRACS function.

Qualifications

Education:

- B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development experience in regulatory affairs
- M.S. with minimum of 10 years drug development experience in regulatory affairs
- M.D. with minimum of 5 years regulatory experience
- PhD with minimum of 7 years relevant regulatory experience
Required:

- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead
Preferred:

- Oncology experience
- Immunology and biologics experience
- Substantial experience in regulatory affairs regulatory marketing applications, oncology clinical experience with direct experience in one major country/region (eg. USA, EU)

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


Job: Regulatory Affairs Liaison

Job Title:Sr. Prin. Scientist, Regulatory Liaison

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Company Trade Name:Merck