- 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.
- Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
- 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.
- Ability to develop regulatory strategies for CMC in accordance with scientific and technical criteria
- Manage the resolution of regulatory CMC issues with clients
Directly supervises employees if required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Bachelors’ degree in area of concentration commensurate with responsibility.
- US add'l:
- Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.
- EU add'l:
- Post-graduate degree (MSc or PhD) and leadership role in academia or pharmaceutical industry highly desirable.
- APAC add'l:
- 10+ years’ work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.
- Experience working in academic, pharmaceutical, biotechnology or CRO industry preferred.