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Manager of Regulatory Affairs - (CONTRACT) - Immediate Opening

Location: PA
Industry: Pharmaceutical/Biotech
Job Code: 12024-12

This is a 6 month contract with potential to go to permanent. Compensation is based on an hourly bill rate and paid out bi-monthly. There are no direct reports. The Regulatory Affairs Manager will serve as a Regulatory Affairs (RA) representative on project teams.

• Manages the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies for assigned projects.
• Serves as FDA contact for assigned projects.
• Works with senior management and RA representatives from other sites to assess regulatory issues as they relate to assigned projects and participate in the development of strategies.
• Monitor current and proposed regulatory and legal requirements in order to provide key regulatory advice to project teams and commercial operations for investigational and marketed products that comply with corporate and regulatory requirements.

Responsibilities :

• Regulatory Affairs Representative on Project Teams:
• Work with management and Project Team members to develop strategies and advice for addressing the issues for developmental and marketed products.
• Represent the company during interactions with regulatory agencies.  Makes arrangements for regulatory agency meetings (face-to-face and teleconferences).
• Prepares records of regulatory agency interactions.
• Preparation and Submission of Regulatory Applications:
• Prepare or manage the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies. 
• Schedule, coordinate, prepare, and review Investigational Applications (original submissions and amendments) and Market Applications (original submissions and supplements) in cooperation with the Project Team members.
• As assigned, review advertising and promotion pieces.
• Regulatory Intelligence:
• Maintain an intimate knowledge of regulations, particularly for biologics, including proposed and final rules; assure that awareness of these regulations exists within the department.
• Maintain an intimate knowledge of corporate policies and procedures as they relate to developmental and marketed products.
• Monitor current and proposed regulatory and legal issues through external meetings, workshops, and the Internet.
• Standard Operating Procedures/Local Working Practices:
  • Author and maintain Standard Operating Procedures and Local Working Practices as assigned.

Education Requirements:

BS, BA in Life Science or advanced degrees
Regulatory Experience 5 to 7 years with 6 to 9 years of pharmaceutical or related experience
*Must have exceptional organizational skills and knowledge of FDA regulatory requirements and ICH guidance. Interpersonal, administrative, written and verbal skills required. Requires a self-starter with the ability to work on his/her own as well as define, coordinate and direct assignments to project team members.

Contact:

For more information on this or any of our other available positions or to be contacted by one of our staffing specialists, please send us your resume, cover letter and RegExec job code to resume.

PLEASE NOTE: All resumes that are received by RegExec will be thoroughly reviewed by one of our staffing specialists and treated confidentially.