Regulatory Affairs Manager at The Ritedose Corporation in Columbia, South Carolina

Job Description:

The Regulatory Affairs Manager performs routine regulatory surveillance, pre- and post-approval submissions, accreditations, state licensing/product stewardship, and 503B / DEA compliance activities.

Responsibilities:

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


• 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.


• Review change control requests and assess the regulatory impact of post approval CMC changes.


• Review labeling for compliance with FDA regulations and industry standards.


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


• Review and approve documents for product development activities.


• Obtain and maintain accreditations.


• Verify state licenses during the 503B customer intake process.


• Ensure that 503B products comply with the Compounding Quality Act.


• Submit 503B biannual product listings to FDA.


• Obtain and maintain 503B registrations and licenses for the production of controlled substances.


• Submit procurement quota applications to the DEA for controlled substances.


• Submit ARCOS reports to the DEA for controlled substances.


• Point of contact for the state licensing and product stewardship consulting groups.


• Other duties as assigned.

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


• 503B outsourcing facility experience is a plus.


• Proven science-based decision making skills


• Thorough knowledge of cGMP guidelines and current industry standards


• Experience with eCTD format requirements and software


• Proficient with current MS Office word processing and database software


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


• Excellent written and verbal communication skills and strong interpersonal skills