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.
Responsible for developing product regulatory strategy for assigned products, with aim 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. Lead liaison for programs where: the compound is first-in-class, or is in a new therapeutic area for Merck, and/or no regulatory guidance exists; timelines are extremely accelerated; there is a Joint Venture; there are multiple indications, the filing is global. 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/or marketed Infectious Disease Small Molecule/Vaccine/Biologic. 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 (PDT) 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 Executive Director, Therapeutic Area Lead, Antivirals
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
- Leads the Global Regulatory Team (GRT) which coordinates cross-functional regulatory support for development programs and marketed products.
- As the strategic regulatory expert, advises CMC Regulatory Affairs on the regulatory impact of Chemistry, Manufacturing and Control changes on registration strategies and coordinate timing of CMC variations with clinical variations.
- Reviews and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
- Acts as the Merck regulatory liaison with the U.S. FDA; responsible for formal submissions as well as direct communication with the FDA, through telephone calls and e-mail; chairs meetings between Merck and FDA; prepares Merck teams for meetings with FDA at all phases of drug development. Leads cross-functional efforts to prepare for advisory committee meetings (ACM), and may present at ACM.
- Coordinates interactions with foreign regulatory agencies through Regulatory Affairs Europe (RAE) and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
- Reviews and provides final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from Merck to external agencies and investigators.
- Provides expert advice to Product Development Teams (PDT) and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
- Represent GRACS within internal Merck committees to provide regulatory advice and approval according to the committee charters (Therapeutic area document review committees (DRC ), GRT, PDT, Early Development Team (EDT), Label as Driver (LAD), and LEAD (Label Evaluation and Development Team).
- Conducts initial IND/CSA content review and approval to facilitate initial approval by regualtory agencies for conduct of clinical trials.
Education Minimum Requirement:
- M.D. or PhD or other related doctoral degree in biological science, chemistry or related discipline required. M.S. (see below).
Required Experience and Skills:
- M.D. with minimum of 5 years drug development or clinical experience; PhD 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, a majority of which was in Regulatory Affairs.
Preferred Experience and Skill:
- Anti-viral, antibacterial, and /or antifungal knowledge and experience; Infectious Disease experience/expertise and/or Vaccine expertise.
- Substantial experience in regulatory affairs and administration.
- Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
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