Merck Director Global Regulatory Affairs Lead – Vaccines/Infectious Disease in Upper Gwynedd, Pennsylvania
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.
The Director, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease (Antivirals) 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 Associate Vice President, 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.
Provides expert advice to Product Development Teams (PDTs) and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
Provides leadership to the staff by leading the Global Regulatory Team (GRT) which coordinates cross-functional regulatory support for development programs and marketed products.
Represents Merck with external organizations through direct communication with the FDA, including 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 committees and may speak at the advisory committee.
Coordinates interactions with foreign 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, Investigators’ Brochures before release from Merck to external agencies and investigators.
Represents 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 Label Evaluation and Development (LEAD) Team.
Conducts initial IND/CSA content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.
Participates in regulatory due diligence activities for licensing candidate review.
Education Minimum Requirement:
M.D. or Ph.D. in biological science, chemistry or related discipline preferred. Other degrees such as M.S. with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.
Required Experience and Skills:
Regulatory experience preferred with therapeutic area experience in Infectious Diseases.
M.D. with minimum of 3 years relevant drug development or clinical experience required;
PhD with minimum of 5 years relevant drug development experience required.
M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in Regulatory Affairs.
Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
Preferred Experience and Skills:
- Antivirals/Infectious Diseases experience/expertise. Substantial experience in regulatory affairs.
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.
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Visa sponsorship is not available for this position.
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Job Regulatory Affairs Liaison
Other Locations: NA-US-NJ-Rahway
Title: Director Global Regulatory Affairs Lead – Vaccines/Infectious Disease
Primary Location: NA-US-PA-Upper Gwynedd
Requisition ID: REG003743