Regulatory Affairs Manager

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Regulatory Affairs Manager

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Work Location: Tevogen R&D Center, Philadelphia PA 19107
Division/Department: Research and Development
Reports to: Chief Scientific Officer
Position: Full-time, Exempt

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Essential Duties and Responsibilities:

The Regulatory Affairs Manager is responsible for support regulatory activities related to product development, ongoing clinical trials, quality assurance, and data reporting for post-marketing studies. Specific functions include:.

• Provide FDA compliant regulatory support and consultation in the development of new protocol submissions:
  • Collaborate with and advise R&D personnel in the formulation of new Investigational Drug Exemption (IND) applications required to conduct new protocols.
    • Specific areas of guidance in new IND applications and clinical trials include, but are not limited to, interpretation and adaptation of FDA guidance in product manufacturing, labeling, adventitious testing, storage and transport, clinical trial adverse event reporting to the FDA and to local IRBs, safety considerations of proposed clinical trials, and safety monitoring plan.
  • Manage the submission of all regulatory documents required for new IND submission.
  • Arrange, conduct, and follow up on all meetings with the FDA as needed for new product development.
  • Provide support for the timely preparation, editing and review of submissions, including regulatory agency Meeting Requests and Briefing Documents, IND/CTA amendments, original Marketing Authorization Applications, and their respective amendments/supplements. Advise and collaborate with clinical trial sites on regulatory requirements.
  • Assist in the education of personnel from Clinical Research Organizations (CRO) regarding regulatory requirements for new studies.
  • Participate in the development of the product pipeline.
• Provide FDA compliant regulatory support and consultation in the conduct of ongoing clinical trials:
  • Respond to inquiries from regulatory authorities, including the FDA.
  • Prepare and compile abbreviated new drug applications (ANDA), Amendments, Supplements, Annual Reports, 502(b)(2) and 505(b)(1) filings, ensuring that they comply with applicable regulatory guidelines and that the highest standards are met.
  • Provide regulatory expertise to CROs and clinical trial sites in preparing institutional and FDA required reports.
  • Critically review documentation intended for submission to the FDA for consistency relevant to FDA guidelines.
  • Remain informed of new or updated guidance from the FDA and assess the impact to planned and ongoing Tevogen clinical trials and drug manufacturing.
• Assist in the development and data reporting of post-marketing studies as required by the FDA.
• Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.
• Collaborate with the Chief Scientific Officer and the Chief Technological Officer in implementing a set of laboratory and clinical processes and controls that all data collected during manufacturing, clinical trials, and research is accurate, complete, consistent, and current.
• Collaborate and engage with affiliated CROs regarding ongoing monitoring of data accuracy, data extraction accuracy, compliance with collected clinical trial data
• Assure the accurate and timely reporting of adverse events to the FDA

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  Full Job Description

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