7 months ago
Job Title: Director, Regulatory Affairs - CMC
Job Location: United States, Remote
Responsible for the delivery of or oversight and management of allocated projects, with a primary focus on CMC, including regulatory authority licenses, registrations, exemptions, designations, applications or authorizations for marketing and sale of a drug product or for the use of an investigational drug in human subjects. The Director will develop regulatory plans and strategies for emerging and mid-tier life science client companies. The position will also include client and regulatory authority liaison.
Job Duties and Responsibilities:
- Plans regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- Develop, lead, and drive CMC regulatory strategy for development projects and marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
- Emerging senior level position primarily devoted to development of strategic approaches to reconcile regulatory issues and expedite regulatory submissions
- Lead and drive all CMC content for submission activities (planning, authoring, reviewing, coordination, submission) for across all stages of development for pharmaceuticals and/or biologics.
- Serve as RA CMC liaison with the FDA and develop global regulatory contacts
- Conduct and participate in meetings with regulatory authorities.
- Establish, manage, and maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to colleagues
- Provide CMC regulatory expertise for new business development/due diligence activities.
- Stay abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development.
- 10+ years’ of Regulatory Affairs CMC experience; or combination of work experience, education or other related industry experience in similar role.
- Module 2 and Module 3: IND/NDA or IND/BLA authoring experience
- Experience with both NDA and BLA a plus
- Cellular or gene therapy experience a plus
- Analytical chemistry background/experience preferred
- Experience with FDA agency interactions is a plus