The Associate Director of Global Regulatory Affairs Strategy (GRAS) will be responsible for leading the GRAS function within Global Regulatory Affairs (GRA), work closely with sponsor companies in developing regulatory strategies that support product development initiatives in Japan. This responsibility will include leading client interactions with Regulatory Agencies in Japan. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactical plans to meet their product development needs.
Collaborate closely with internal Covance project teams in the design and development of regulatory strategies for client projects or to answer client inquiries.
Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by EMA, FDA, Health Canada, and elsewhere.
Interact and collaborate with all Covance business unit personnel
Establish productive working relationship and collaborate closely with the Global Regulatory Submissions and Medical and Regulatory Writing functions leadership.
Create and build confidence by representing the GRAS function as an informed, capable, knowledgeable, responsible and accessible resource to Covance staff, management and clients, positioning Covance as a preferred source for regulatory strategy expertise.
Build successful working relationships with business and scientific leaders across Covance.
Provide regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.
Actively plan and execute on business development activities to raise awareness and promote GRAS capabilities to new and existing clients.
PharmD, MD or PhD in a life science, pharmacy or medicine is required.
At least 10 years experience of drug development in the Pharma, Biotech or CRO industry with experience in regulatory affairs developing global regulatory strategies for early and late stage product development programs.