Associate Director/Director, Regulatory Liaison (RY or UG) -MERCK-USA - PA - Upper Gwynedd

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. 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 Associate Director/Director, Principal Liaison is responsible for developing the global regulatory strategy for assigned Oncology products, in order to obtain the optimal product label and shortest time to approval by regulatory agencies. Independently manages projects within Oncology; 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 with one or more Merck investigational and marketed drugs/ Vaccines/Biologics. Responsible for 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 worldwide for products within Global Strategic Regulatory Development (GSRD) and external to GSRD.

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