Associate Director, Regulatory Affairs Strategy

Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. The candidate will manage and lead regulatory submission-related activities associated with the US and ex-US fillings for assigned products, ensure timelines are appropriately managed and met, and issues are appropriately raised and resolved in a timely manner. Represent regulatory affairs on assigned project teams and support R&D and clinical research activities.

• Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable.
• Provides regulatory strategic support and guidance to project teams.
• Mentor and management of direct reports.
• Performs research on regulatory precedence and competitive intelligence as needed.
• Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submissions and approvals.
• Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines.
• Supports and manages regulatory CROs in the planning and execution of US and ex-US global health authority interactions including support of preparation and submission of meeting requests, briefing books, meeting preparations, Pediatric Investigational Plans (PIPs), Orphan Drug Designation applications, Fast Track and Breakthrough Designation requests, Rare Pediatric Disease Designations, etc., as applicable
• Assists and/or leads in planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines.
• Interprets and communicates health authority correspondence effectively and quickly to senior leadership and project teams.
• Participates in project team meetings and provides updates on regulatory activities

Qualifications:

• Driven self-starter, able to prioritize and work well in a fast-paced environment to multi-task, problem solve, motivate and lead others.
• Willingness to take on tasks outside normal responsibilities with a positive attitude to get the job done.
• Management of direct reports.
• Ability to contribute to the development of regulatory strategy, as well as, lead and or contribute to hands-on day-to-day submission activities.
• Able to present information to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.
• Strong sensitivity for a multicultural and multinational environment.
• Experience in submission and maintenance of INDs/NDAs, preparation of FDA correspondence and other regulatory documents.
• Experience in preparation and review of FDA meeting requests, briefing documents, designation requests and other regulatory documents.
• Excellent written and verbal communication skills and strong analytical skills.
• Experience in managing regulatory CROs and consultants is a plus.
• Experience with regulatory strategy support of Branded pharmaceutical products is required.
• Experience with rare diseases, orphan drug products, accelerated approval process is a plus.
• Experience with NDA submissions and post approval requirements is a plus.

Education/Experience:

• BS/BA in Life Sciences in a relevant field required; advanced degree strongly preferred (PharmD, MD, PhD) with 7-10 years of regulatory experience in the branded biotech/pharma industry supporting regulatory strategy, submissions, drug promotion/advertising and US labeling.
• Working knowledge of prescription drug laws, ICH and FDA guidelines, FDA regulations and other health authority guidelines.
• Experience in rare disease/accelerated approvals preferred.
• Regulatory Affairs Certified is a plus.