Regulatory Affairs Associate Director - (Job Number: 0806020)

Regulatory Affairs Associate Director - (Job Number: 0806020) DescriptionJohnson & Johnson Consumer Products Company, a Division of Johnson & Johnson Consumer Companies, Inc. is currently recruiting for a Regulatory Affairs Associate Director located in Skillman, NJ. Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S Baby and BAND-AID Brand, as well as leading skin care brands such as AVEENO and CLEAN & CLEAR. The Regulatory Affairs Associate Director position is responsible for supporting new product development activities as well as marketed product labeling, advertising, and promotion and will be assigned to products and teams in the Beauty Global Business Unit. Primary responsibilities include providing regulatory strategies to development teams for in multiple product classifications (i.e., drug, device, cosmetics), preparing Health Authority applications when needed (e.g., IND, NDA or 510(k)), and review and approval of product labeling, advertising, and promotion. Responsibilities will also include interaction with FDA or other regulatory agencies throughout the development and marketing of assigned products as well as working with regional colleagues in support of global launches and issue management. In addition, this position will be responsible for review of competitive activities and will be expected to keep current on health authority guidelines and polices that contribute to optimal regulatory strategies. A minimum of a Bachelors degree in a health science or a related field required. A Master's degree or Ph.D. is a plus. A minimum of 8 years' industry experience, with at least 6 years in Regulatory Affairs and minimum 2 years experience with OTC drug and cosmetic products is required. Previous management experience is preferred. Experience working cross-functionally is required. Previous experience with topical beauty products is a plus. Superior interpersonal, communication and organization skills with attention to detail are required. Candidates should have a working knowledge of FDA requirements and guidelines. Must be able to work independently as well as in a team environment. Approximately 10% domestic and international travel is expected. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now