Director / Sr. Director, Regulatory Affairs

Director / Sr. Director, Regulatory Affairs

Adolor Corporation is a biopharmaceutical company located in suburban Philadelphia specializing in the discovery, development and commercialization of novel prescription pain management products. Adolor has more than 120 employees working in areas including discovery research, drug development, clinical research, manufacturing, business development and marketing.

The Director / Sr. Director Regulatory Affairs will provide specific and value added regulatory guidance for all existing and future submissions. Will formulate and recommend company’s position on regulatory matters concerning policy and objectives when responding to quality investigations or governmental proposals. Will be a contributing member of a collaborative project team addressing company policy, regulatory strategy, business goals and direction and serve as a key liaison by representing the company and its products to outside consultants, organizations, and government agencies. Will provide direct support to the Vice President, Regulatory Affairs on all Regulatory Affairs concerns and will prove guidance and direction to the Regulatory Affairs support team.

RESPONSIBILITIES:
Participate in and lead the development of clinical trial applications and new marketing applications.Provide regulatory strategy and operational support for development programs, serving as the Regulatory Affairs representative on relevant project teams and serving as the regulatory contact with the FDA and other regulatory agencies.Provide guidance and review of submissions to ensure accurate information and regulatory compliance.Interact with the R&D functions and participate in the planning and development of new products to assure successful application reviews and product launch, including labeling and promotional piece review and approval.Help interpret/enforce SOP requirements and cGxP regulatory guidelines.

JOB QUALIFICATIONS:
BS/BA or MS/MA degree in a scientific discipline required. An MBA or PhD degree a plus.Minimum of 8 years Regulatory Affairs with at least 4 years experience in pharmaceutical small molecule product development.Demonstrated experience in submission preparation involving paper as well as electronic regulatory submissions.Significant experience in direct CDER FDA negotiation and liaison at the appropriate agency levels is required, as well as experience in life-cycle management and brand defense.Must possess familiarity with current drug regulations and knowledge of FDA organizations.Excellent organizational, communication and interpersonal skills are imperative.

Qualified candidates should forward a resume along with a cover letter indicating position desired to mmurray@adolor.com and reference RA0430