Executive Director Regulatory Affairs


Opportunity Profile:
Reporting directly to the Vice President, Regulatory Affairs, the selected candidate will be responsible for the day-to-day operations of the new (branded) drug section of the Regulatory Affairs Department, with specific emphasis on the preparation, review and evaluation of documents for FDA submission. This position is responsible for assuring that all regulatory requirements/commitments are met with respect to the development and approval of new (branded) drug products and maintenance of applications for products currently approved for marketing. The person in this position also provides regulatory advice and counsel to other functional areas with regard to the regulatory aspects of drug development and marketing and interacts directly with FDA personnel via written correspondence, teleconferences and meetings.

Qualifications:
The successful candidate will possess a B.A. or B.S. degree in science or health-related discipline and 18 years pharmaceutical industry or related experience with 12-15 years experience in a pharmaceutical regulatory affairs environment. A M.S. or Pharm.D. degree with a minimum of 16 years pharmaceutical industry or related experience with a minimum of 10 years in pharmaceutical regulatory affairs environment will also be considered. A Ph.D., M.D. or J.D. degree with a focus in science or health related discipline with a minimum of 13 years pharmaceutical industry or related experience with a minimum of 6 years in the pharmaceutical regulatory affairs environment will also be considered. Must possess experience in the development of new drug products with a working and practical knowledge of Federal laws, regulations (21 CFR), guidelines, policies and procedures related to drug development, registration, review and approval, including a solid understanding of the USP, cGMPs, cGCPs, and cGLPs. Additionally, this individual must have excellent project management, interpersonal and consensus gathering skills, a strong work ethics and exemplary written and verbal communication skills. An individual must be well organized, attentive to detail, even-tempered and capable of providing support and direction to others. Applicable computer skills in a Windows-based environment are also necessary.