Associate Director of Regulatory Affairs

08 Mar, 2021

Jobs

Associate Director of Regulatory Affairs

Pharmaron
Baltimore, MD

Job Specification

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.

Essential Functions

  • 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.

 

Qualification

  • 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