Associate Director of Regulatory Affairs
Shirley, NY 11967
Our client is a major force in the Pharmaceutical community. They have asked us to identify and refer an Associate Director of Regulatory Affairs Strategy who is ready to join an exciting, cutting-edge organization strongly committed to the development of its employees as leaders.
Working in a matrix environment you will be responsible for developing and translating regulatory requirements into regulatory strategies, objectives, policies and programs pertaining to the development of new products in the US and other emerging markets. Core responsibilities include activities pertaining to regulatory strategy and submissions to the FDA and other Health Authorities (EU and Canada) and providing regulatory advice to multidisciplinary teams on regulatory requirements to support registrations, including preparation and maintenance of IND, NDAs, CTAs, NADA and ANDAs. This position will include the supervision and management of regulatory professionals and support personnel.
This employer has experienced tremendous growth over the last few years with the introduction of new products. They are committed to bringing the highest quality products and service to the healthcare community's growing demands. Their culture is responsive to employees and their benefits program is comprehensive and forward thinking to today's life/work balances.
- Bachelor’s degree in science or related field required, advanced degree preferred.
- Regulatory Affairs certification (RAC) is a plus.
- Minimum of 7 years of experience in the Pharmaceutical or Biotechnology industry with strong Regulatory Affairs experience.
- Proven experience training and mentoring staff, managing direct reports, teams and multiple projects.
- Direct experience working with regulatory submission preparation across all stages of development.
- Excellent oral, written, analytical and communication skills.