Associate Director, Regulatory AffairsWednesday, May 9th, 2018
Title: Associate Director, Regulatory Affairs
Location: Northern NJ, Bergen County
This is a Direct Hire position
Relocation is an option for the right candidate
Responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Oncology agent.
In addition, this position will serve as the lead support for early phase Oncology compounds.
May participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.
Responsibilities include but are not limited to:
- 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 aligns 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). Leads 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. Identifies, monitors and resolves regulatory issues and reports progress to management
- Compliance: Ensuring compliance with all applicable laws / regulations of each country in which we do business. Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reports 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 in Life Sciences in a relevant field with 10+ years of broad pharmaceutical experience, including 6+ years of new drug regulated product strategy/submissions
a Master’s Degree with 8+ years of related Regulatory experience, including fellowship experience or a PharmD or PhD with 5+ years of related Regulatory experience, including fellowship experience.
• 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