Founded in 1997, GTx, Inc. is a biopharmaceutical company dedicated to the development and commercialization of therapeutic products related to men's health. The company's drug discovery and development programs are focused on small molecules that selectively target nuclear hormone receptors for estrogens and androgens. These nuclear hormone receptors are among the best-understood receptor systems, and pharmaceuticals have been developed to either stimulate or block these receptors for over 50 years.

To this end, we are actively recruiting for the following position:

Regulatory Affairs, Associate Director

Role:

The Director is the mid-senior level professional and managerial position in the Regulatory Affairs Department. This individual serves as a primary regulatory resource for development initiatives and provides department and team leadership for the development and execution of regulatory strategies. The Principal Regulatory Scientist has primary responsibility for interactions and negotiations with drug regulatory agencies (US and non-US) on assigned projects and manages the project activities of other regulatory staff assigned to projects under their authority.

Responsibilities:

• Serves as the primary Regulatory Affairs representative to assigned Product Development Teams(s) and interacts with other departments and with personnel from corporate partners.
• Participates in development of overall project goals and in particular those that pertain to regulatory affairs.
• Develops regulatory strategies and position papers for development candidates, submissions, drug regulatory agency meetings and special regulatory issues.
• Responsible for negotiations and interactions with drug regulatory agencies on assigned projects.
• Coordinates preparation of information and development of strategies for meetings with drug regulatory agencies. Responsible for managing the conduct of meetings when appropriate and responsible for meeting minutes.
• Responsible for organizing regulatory submission teams and coordinating the drafting, editing and preparation of regulatory submissions, (e.g., IND’s, NDA’s, annual reports, IND amendments, NDA supplements, routine correspondence).
• Participates in the development, implementation and enforcement of regulatory policy.
• Negotiations with and supervision of contract organizations employed for the preparation of regulatory submissions.
• Advises relevant corporate personnel regarding regulatory strategies, potential areas of concern and new governmental/regulatory developments.
• Determines methods and procedures that are to be followed for projects assigned and may manage the activities of other regulatory staff assigned to their projects.
• Responsible for the regulatory evaluation of in-licensing candidates as assigned.

Discretion/Latitude/Independence

• Receives general goals of new assignments and is expected to develop an appropriate plan of action or strategy to accomplish the assignment.
• Receives general instructions on work to be accomplished.
• Exercises judgment within the defined policies and practices of GTx Regulatory Affairs in selecting methods and techniques for obtaining solutions.

Primary Contacts:

• Other Regulatory Affairs staff
• Clinical Affairs staff working on common projects
• Project teams
• Regulatory agency staff
• Corporate partners project staff

Qualification:

• Excellent oral and excellent written communication skills
• Detailed knowledge of current FDA and EMEA regulations and guidelines
• Detailed understanding of U.S. regulations pertaining to the manufacture and distribution of biologics and drugs. Knowledge of foreign biologic or drug regulations.
• Experience in management of teams responsible for the preparation, and submission of INDs, CTAs and amendments, annual reports, and safety reports.
• Experience in management of teams responsible for the preparation, submission and approval process for CTD’s, NDAs, MAAs, and supplements.
• Experience in managing and conducting meetings with regulatory agencies .

Education Requirements:

• Graduate degree in pharmacy, life science or commensurate experience.
• 7+ years of related experience with at least 4-5 years of Regulatory Affairs experience with increasing responsibility. A Master’s Degree or PhD may partially substitute for work experience.Experienced in the process of interacting with regulatory authorities.
• Knowledge of ICH/GCP, GLP and GMP requirements.
• Must be able to effectively interact with internal and external customers to obtain accurate information and be a team player.
• Must posses the ability to manage multiple projects with competing deadlines.

Compensation:

The salary and benefit package will be very attractive and highly competitive with prevailing market standards.

Interested candidates should submit resume, list of professional references, and salary requirements to: Human Resources. GTx, Inc. 3 North Dunlap Street, Memphis, TN 38163. Or, CV's can be submitted electronically to: careers@gtxinc.com . Please include the position title in the subject line.