Associate Director Regulatory Affairs Strategy

Job Summary:

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 submission related activities associated with the US and ex-US fillings for product, ensure timelines are appropriately managed and kept to, and issues are appropriately raised and resolved in a timely manner.

Essential Duties and Responsibilities:

(Include but not limited to the following. Other duties may be assigned)

1. Serves as a liaison to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. May provides oversight to regulatory consultants and vendors where applicable.
2. Provides regulatory strategic support and guidance across all functions.
3. Routinely performs regulatory precedence and competitive intelligence research.
4. Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submission and approval.
5. Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines.
6. Supports and/or leads the planning and execution of global health authority interactions including support in generation and submission of briefing books, meeting preparations.
7. 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.
8. Interprets and communicates health authority correspondence effectively and quickly to senior leadership and project teams.

Qualifications:

1. Driven self-starter, able to prioritize and work well in a fast-paced environment to multi-task, problem solve, and motivate and lead others.
2. Willingness to take on tasks outside normal responsibilities with a positive attitude to get the job done.
3. Ability to contribute to the development of regulatory strategy, as well as, leading and or contributing to hands-on day-to-day submissions activities.
4. Able to present to senior leadership clearly, succinctly, with open-mindedness and willingness to defend difficult positions.
5. Strong sensitivity for a multicultural and multinational environment.
6. Excellent written and verbal communication skills, strong analytical skills.

Education and/or Experience:

1. 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.
2. Working knowledge of prescription drug laws, ICH and FDA guidelines, FDA regulations and other health authority guidelines.
3. Experience in rare disease/accelerated approvals preferred.
4. Regulatory Affairs Certified is a plus.