Associate Director of Regulatory Affairs
We are looking for a Associate Director of Regulatory Affairs to work on a full-time basis at our Baltimore, MD facility.
This position is responsible for planning, directing, or coordinating regulatory submission activities for sponsors to ensure compliance with regulations and standard operating procedures.
- Works closely with clients to formulate an IND filing strategy prior to the start of any IND-enabling activities to ensure the studies are designed fulfilling the FDA’s IND requirement and tailored to the clients’ needs.
- Prepares and/or guides clients in the preparation of high-quality safety assessment, DMPK, pharmacology/biology sections of regulatory documents including but not limited to IND and NDA.
- Responsible for the investigational submission lifecycle maintenance of clients.
- Collaborates with BD during contract negotiation to provide insight and guidance regarding scope of work pertaining to IND submission.
- Prepares and/or reviews all IND applications for submission; submit sponsor IND applications, electronically to the FDA.
- Provide responses to regulatory agencies regarding clinical research or IND submission issues.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new drugs.
- Manage activities such as audits, regulatory agency inspections.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Train staff in regulatory policies or procedures.
- Develop and maintain SOPs for IND submission processes and maintenance.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed policy regulations.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- Facilitate communication and collaboration internally and/or with the sponsor to ensure mutual clarity amongst multidisciplinary teams to ensure the IND application is clear and precise for regulatory acceptance.
- Facilitates and maintains correspondence with the FDA on behalf of sponsor which may include hosting meetings, phones, calls and/or other necessary regulatory documentation.
- Maintain a listing of all protocol deviations, serious adverse events, unanticipated adverse events and deaths to include in the IND annual report to the FDA.
- Ensures IND maintenance on behalf of the sponsor.
- Works both internally to assist in regulatory insight for study/protocol development and independently with the sponsor directly on IND submissions relating to studies which may not be executed outside of Pharmaron.
- Acts as a U.S. Agent for a foreign establishment to (a) review, disseminate, route, and respond to all communications from FDA including emergency communications; (b) respond to questions concerning those drugs that are imported or offered for import to the United States; (c) assist FDA in scheduling inspections; and (d) If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA’s providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.
- Ph.D. in toxicology, biology/pharmacology, DMPK, or related field with at least 5 years related experience; OR M.Sc. in in toxicology, biology, pharmacology, DMPK, or related field with at least 8 years related experience; OR B.Sc. in toxicology, biology, pharmacology, DMPK, or related field with at least 10 years related experience.
- Possess at least 5 years of safety assessment, DMPK and pharmacology authoring experience.
- At least 5 years of experience working with regulatory submissions in drug development environment.
Learn more here
Job posted: 2021-03-08