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, Manager

Role:

Manager, Regulatory Affairs is a senior level professional position in the Regulatory Affairs department. The Manager has primary responsibility for interactions and negotiations with domestic and foreign regulatory agencies on assigned projects, and manages the activities of other regulatory affairs staff in the performance of the duties outlined below.

Responsibilities:

• Has primary responsibility for coordinating the drafting, editing and preparation of regulatory submissions, (including routine correspondence, IND's, BLA’s, NDA's, annual reports, amendments orphan drug applications, supplements, etc.) Manages internal and external activities to ensure the prompt provision of information necessary for such submissions.
• Has primary responsibility for negotiations and interactions with domestic and foreign regulatory agencies on assigned projects.
• Participates in the development, implementation and enforcement of regulatory policy.
• Advises relevant corporate personnel regarding regulatory strategies, potential areas of concern and new governmental/regulatory developments. Assists in project planning and time-line development.
• Serves as the Regulatory Affairs representative to assigned Product Development Team(s) and interacts with other departments, Country offices and with personnel from corporate partners in order to achieve common goals.
• Manages domestic activities in support of international submissions as an integral member of international Project Development Teams.
• Performs audits of facilities (manufacturing, testing, distribution operations, clinical sites, sales and marketing, medical affairs, professional services, etc.) and contract operations (toxicity, testing, filling, etc.).
• Reviews labeling, advertising and other promotional materials. Assesses the state of compliance with appropriate regulations; provides specific detailed actions to correct deficiencies.
• Negotiates, interacts with, and supervises the activities of contract organizations in the preparation of regulatory submissions, as necessary.
• May determine methods and procedures on new assignments and may manage the activities of Senior Regulatory Affair Associates and Regulatory Affairs Associates in the conduct of their duties.

Discretion/Latitude/Independence:

Normally receives no instructions on routine work, general instructions on new assignments.

Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Primary Contacts:

• Regulatory Affairs staff
• Clinical Affairs staff,
• Nonclinical staff,
• Manufacturing staff
• Product Development Teams

Qualifications:

• Good oral and excellent written communication skills; strong work ethic; attention to detail; strong initiative; leadership qualities.
• Detailed knowledge of current Good Manufacturing Practices (cGMP's), Good Clinical Practices (GCP's). Knowledge of foreign regulations pertaining to the manufacture and distribution of biologics or drugs is helpful.
• Experience in the preparation of various submissions such as of IND's, NDA's, annual reports, amendments and supplements.
• Computer skills-proficiency in standard office productivity software

Education Requirements:

Bachelor's degree (as a minimum) in a scientific discipline.

5-7 years of related experience with at least 3-4 years of Regulatory Affairs experience with increasing responsibility. A Master’s Degree or PhD may partially substitute for work experience.

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.