The Regulatory Affairs Manager performs routine compliance activities, licensure, pharmacovigilance, and pre- and post-approval submissions.

Responsibilities:

• Monitor state and federal regulations and assess the impact of new or revised requirements.


• Obtain and maintain federal and state registrations for various business functions.


• Manage the product stewardship program and submit required documentation to the applicable authorities.


• Obtain and maintain accreditations.


• Prepare, compile, and publish regulatory submissions in compliance with FDA content and format requirements for eCTD submissions; demonstrate independence with routine submissions.


• Provide CMC support for client applications in the U.S. and ROW.


• Assess the regulatory impact of post approval CMC changes.


• Review promotional and advertising materials for compliance with regulations and submit to FDA.


• Review and approve documents for product development activities.


• Review Adverse Event intake forms for accuracy. Submit eCTD compliant Periodic Reports to FDA.

Key Interactions/Relationships

• Maintain excellent relationships with TRCs employees, clients, Third Party vendors and regulatory agencies.


• Active participation, communication and partnership with internal and external stakeholders.


• Collaborate with the Director of Regulatory Affairs on regulatory strategies and risks.

Qualifications:

• Four year college degree in Pharmaceutics, Chemistry, or related field


• 5 to 7 years experience in the pharmaceutical industry with regulatory responsibilities


• Proven science-based decision making skills


• Thorough knowledge of cGMP guidelines and current industry standards


• Demonstrated creative, innovative thinking


• 2 years of experience interfacing directly with the FDA


• Experience with eCTD format requirements and software


• Proficient with current word processing and database software


• Strong interpersonal/group skills with ability to motivate and direct others