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 TRC’s 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
