Director, Global Regulatory Lead, Regulatory Affairs, Oncology job in Upper Gwynedd
|Employer:|| Merck & Co.|
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, Global Regulatory Lead, 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 Executive Director, Global Regulatory Affairs Oncology
•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
•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
•Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
•Immunology and biologics experience
•Substantial experience in regulatory affairs in one major country/region (eg. USA, EU).
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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