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Global Regulatory Team Lead, Cardiovascular & Respiratory Job

Employer
Merck
Location
Upper Gwynedd PA
Closing date
Aug 3, 2016

Job Details

Global Regulatory Team Lead, Cardiovascular & Respiratory-REG002366

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 Global Regulatory Team Lead is
responsible for developing product regulatory strategy for their assigned
products, in order to optimize label and obtain shortest time to approval by
regulatory agencies. Independently manages projects within Therapeutic Area;
functioning as the single, accountable, global point of contact on those
projects. Functions as first liaison assigned to programs where the compound is
first-in-class, or is in a new therapeutic area for Merck; where no regulatory
guidance exists; where the program is extremely accelerated, is a Joint Venture
endeavor; there are multiple indications, the filing is global and/or it is a
new disease target with no official regulatory guidance. Acts as primary point
of contact with US FDA and as global lead of the global regulatory team (GRT)
for assigned products. Solicits regional GRT member input on registration
requirements to ensure development plans support global registrations for one
or more Merck investigational and marketed drugs. 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 of 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
GRACS.

Primary Activities

Primary activities include, but are
not limited to:

1. Reports to Executive Director, Therapeutic Area
Lead,

2. Develops worldwide product regulatory strategy to
optimize label and obtain shortest time to approval by regulatory
agencies for multiple indications simultaneously.

3. Provides leadership to the staff by leading the Global
Regulatory Team and coordinating cross-functional regulatory support
for development programs and marketed products.

4. Reviews and provides final approval of local
registration study protocols when needed to obtain
marketing authorization in secondary markets.

5. Represents Merck with external organizations through
direct communication with the FDA, including telephone calls and
e-mail; chairs meetings between company and FDA; prepares Merck teams for
meetings with FDA at any phase of drug development. Leads
cross-functional efforts to prepare for advisory committees and may speak
at the advisory committee.

6. Coordinates interactions with foreign agencies through Regulatory
Affair-Europe (RAE) and the subsidiary registration departments to
support their interactions and provide strategic direction across
multiple regions simultaneously.

7. Reviews and provides final approval Worldwide Marketing
Applications, Clinical Study Reports, protocols,

8. Reviews Confidential Investigator Brochures before
release from Merck to external agencies and investigators.

9. Provides expert advice to Product Development Teams and
subsidiaries on regulatory issues as they arise with
the developmental compounds or marketed products throughout the
entire life cycle of the drug.

10. Represent GRACS within internal Merck committees to
provide regulatory advice and approval according to the committee
charters. (Therapeutic area document review committees (DRC ), Global
Regulatory Team (GRT)

11. Represent Regulatory Affairs Product Development Team
(PDT) and Early Development Team
(EDT)

Qualifications

Education:

- M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline preferred. Pharm D or Masters in a Biological science will be considered.

Required:

- M.D. with minimum of 5 years drug development or clinical experience; PhD, Pharm D or other related doctoral degree with minimum of 7 years relevant drug development experience required. M.S. or comparable degree in health professions with minimum of 10 years relevant drug development experience,

Preferred:

- Substantial experience in regulatory.
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.

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.

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.

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

EEOC Poster

EEOC GINA Supplement​



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-PA-Upper Gwynedd

Other Locations: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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