Covance Director, CMC Strategic Product Development Consultant in Princeton, New Jersey
The Director of CMC Strategic Product Development Consulting will work closely with sponsor companies in developing CMC regulatory strategy that will support early development through late-stage (Phase 3, registration, post-approval) initiatives, including both small and large molecules. This responsibility will include leading client interactions with regulatory agencies globally. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant CMC regulatory strategy and tactic plans to meet their drug development needs globally.
Collaborate closely with internal Covance project teams in the design and development of CMC regulatory strategies for client projects or to answer client inquiries.
Within the Strategic Product Development Consulting group provide support and input for projects based on past therapeutic experience and global, regional and local CMC regulatory expertise.
Prepare /revise CMC documentation.
Maintain current knowledge of relevant regulatory environment by reviewing and communicating US and international guidances, laws and regulations, and proposed and final rules, which affect CMC pharmaceutical drug development.
Interact and collaborate with all Covance business unit personnel.
Establish productive working relationship and collaborate closely with Regulatory Submissions staff, Medical Writing, EPDS, and other CMC experts in Covance.
Create and build confidence by representing CMC regulatory strategy as an informed, capable, knowledgeable, responsible and accessible resource to Covance staff, management and clients, positioning Covance as a preferred source for CMC regulatory strategy expertise for small and large molecules.
Build successful working relationships with business and scientific leaders across Covance.
Provide CMC regulatory affairs expertise and support to the business development group in presentations to Pharma/biotech customers when requested.
Minimum of 8-10 years of experience in regulatory affairs CMC or a related pharmaceutical drug development field in the Pharma, biotech or CRO industry, with at least 6-8 years of experience in regulatory affairs developing CMC global regulatory strategies for early and late stage development programs, for small and large molecules.
Advanced degree (M.S. or Pharm.D.) in scientific, Regulatory Affairs, or related pharmaceutical field.
Proven history of finding novel solutions to challenging CMC drug development issues and developing innovative CMC regulatory strategies.
In-depth knowledge of pharmaceutical and biotechnology drug development, and related global CMC regulations/guidelines.
Experience with leading CMC strategic planning, preparation and execution of Agency interactions.
Experience leading CMC teams through IND, CTA development, and addressing Agency questions to support the start up of clinical trials.
Experience in leading CMC teams through NDA/MAA development, submission and addressing Agency inquiries.
Proven leadership role in Health Authorities negotiations in multiple regions/countries.
The ability to develop effective multi-cultural relationships.
Global people management/leadership experience desirable.
Excellent organizational skills and the ability to manage multiple important projects with tight timelines is essential.
- Minimum of 8-10 years of experience in regulatory affairs CMC or a related pharmaceutical drug development field in the Pharma, biotech or CRO industry, with at least 6-8 years of experience in regulatory affairs developing CMC global regulatory strategies for early and late stage development programs, for small and large molecules.
Job Number 2018-18876
Job Category Other
Position Type Full-Time
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