The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Neurology or Oncology agent. In addition, this position will serve as the lead support for early phase Neurology or Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.
- Regulatory Submissions (IND/NDA): Monitoring regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and align resources (i.e., sub teams) to provide regulatory support.
- Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leading calls or meetings with regulatory authorities.
- Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifying, monitoring and resolving regulatory issues and reporting progress to management
- Compliance: Ensuring compliance with all applicable laws / regulations of each country in which we do business. Demonstrating high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reporting legal, compliance and ethical violations in a timely manner
- Life Cycle Management: Leading the planning, execution and assessment of product life cycle management activities and strategies
- BS/BA degree in Life Sciences in a relevant field with 8 or more years of broad pharmaceutical experience, including 5 or more years of new drug regulated product strategy/submissions; or a Master's or PharmD/PhD degree with 6 or more years of pharmaceutical experience and 3 or more years of related Regulatory experience, including fellowship experience, required.
- Experience interacting with the FDA and ex-US health authorities.
- Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document.
- Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams.
- Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines.
- Working knowledge of relevant drug laws, regulations and guidance's/guidelines.