Regulatory Affairs Manager

The Regulatory Affairs Manager will actively participate in the development and implementation of regulatory strategy for specific oncology medicinal products, both human and veterinarian, with the ultimate goal of world-wide registration.Be responsible for the preparation and coordination of the submission of regulatory documents, including, but not limited to, those to support INDs, NDAs, supplemental NDAs, CTDs, IMPDs, Investigators Brochures, Clinical Trial Applications, and other international submissions for product registrations.The Regulatory Manager will represent the department on multidisciplinary product development and must have an understanding of FDA and EU regulations. Qualifications include: a Masters Degree in physical or life sciences with a Doctorate or Pharm.D. preferred; a minimum of four (4) years experience in the pharmaceutical drug development process and regulations with a minimum of four (4) years experience in regulatory affairs; thorough understanding of the drug discovery/development process, cGMPs, cGCP, cGLP; knowledge and understanding of FDA requirements and regulatory guidances; and experience with relevant international requirements and guidances; a successful history of coordination of multi-disciplinary functions; excellent organizational, communication, interpersonal and writing skills; the ability to function both independently and as a team player; experience in oncology products strongly preferred; Proficiency in technical writing and MS office programs is also required.