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 GRACS.
Primary activities include, but are not limited to:
- Reports to Therapeutic Area Lead.
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
- Provide 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.
- Provide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
- Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
- Represents Merck with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare Merck teams for meetings with FDA at any phase of drug development.
- Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
- Coordinate interactions with foreign agencies through RAE and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
- Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from Merck to external agencies and investigators.
- Represent GRA within internal Merck committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and LEAD.
- Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Participate in regulatory due diligence activities for licensing candidate review.
Education Minimum Requirement:
- B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs.
- M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs.
- M.D. with minimum of 5 years regulatory experience.
- PhD with minimum of 7 years relevant regulatory experience.
Required Experience and Skills:
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
Preferred Experience and Skills:
- Oncology experience.
- Immunology and biologics experience.
- Substantial experience in regulatory affairs 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 email@example.com. Search Firm Representatives Please Read Carefully:
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Visa sponsorship is not available for this position.
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