13 days old

Regulatory Affairs Manager

The Ritedose Corporation
Columbia, SC 29201
  • Job Code
    0T44875088

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






Posted: 2021-01-05 Expires: 2021-02-03
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Regulatory Affairs Manager

The Ritedose Corporation
Columbia, SC 29201

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