- Collaborate closely with internal Covance project teams in the design and development of regulatory strategies for client projects or to answer client inquiries.
- Collaborate with the Strategic Product Development Consulting group in providing support and input for one another’s projects based on past therapeutic experience and local regulatory expertise.
- Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by regulatory agencies.
- Interact and collaborate with all Covance business unit personnel.
- Establish productive working relationship and collaborate closely with Regulatory Submissions staff.
- Create and build confidence by representing the regulatory strategy 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.
- experience in discovery research, preclinical pharmacology, toxicology, or clinical research preferred.
- Some CMC experience is preferred
- Proven history of finding novel solutions to challenging drug development issues and developing innovative regulatory strategies.
- Knowledge of regulatory guidance documents and industry best practices for drug development.
- Experience with leading strategic planning, preparation and execution of Agency interactions.
- Experience leading teams through CTA/IND development, addressing agency questions to support the start up of clinical trials
- Experienced in leading teams through NDA/BLA/MAA development, submission and addressing Agency inquiries.
- Leadership role in regulatory agency negotiations
- The ability to develop effective multi-cultural relationships.
- Global leadership experience desirable
- Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential.
- PharmD, MD or PhD in a life science, pharmacy or medicine is preferred.
- 6-8 years’ experience of drug development in the Pharma, biotech or CRO industry with at least 4-6 years’ experience in regulatory affairs developing regulatory strategies for early and late stage development programs.
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