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Job title |
Associate Director, Regulatory Strategy |
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Reports to |
Sr. Director, Regulatory Affairs |
Job purpose
The Associate Director, Regulatory Strategy is responsible for leading the company’s regulatory strategy development and planning related to various products in the company’s pipeline. The Associate Director reports to the Sr. Director, Regulatory Affairs and serves as regulatory affairs leader for strategic planning related to achieving program milestones. The ideal candidate will possess vaccine development and/or cell and gene therapy experience and function collaboratively with key stake holders.
Duties and responsibilities
- Leads strategic discussions with cross functional teams and provide recommendations in support of company goals
- Represents Regulatory Affairs within project teams and provides regulatory guidance to R&D, Clinical Development, Quality and Operations teams as appropriate
- Provides guidance and clear communications of regulatory risk(s) associated with development activities
- Serves as primary point of contact with FDA project manager for assigned projects
- With some supervision, leads the preparation of responses to Health authorities (US & Global)
- Liaises and facilitates meetings with cross functional departments.
- Reviews technical documents for submission in new INDs, BLAs & CTAs and provides guidance to the technical development groups
- Authors and prepares original INDs, CTA, BLA and amendments for submission to Regulatory activities for assigned projects
Qualifications
- Bachelor's degree in a scientific discipline is required, advanced degree is preferred
- Experience in Biologics, cell & gene therapy and/or vaccine submissions and a minimum of 4 years of experience in regulatory affairs with a focus in strategy and communication
- Experience in the preparation and delivery of regulatory submissions and communications to appropriate parties
- Working knowledge of FDA and EMA guidance documents, processes and regulations as well as working knowledge of international (e.g., LATAM and APAC) requirements for investigational and marketed products is required
- Must demonstrate experience managing regional consultants successfully
Working conditions
This position operates in an office setting and may include 20% of travel.
Physical requirements
This position is largely sedentary. There is an expectation of on-site presence at the company’s headquarters atleast 4 days / week.
Direct reports
As the organization grows there is possibility of management requirement