Career Opportunity: Director of Regulatory Affairs

Position Summary

The Director of Regulatory Affairs will report directly to the President and be responsible for managing the regulatory activities for Zynerba Pharmaceuticals (Zynerba) including managing communication with the United States Food and Drug Administration (FDA) and other regulatory agencies, compiling and processing Pre-IND, IND, Annual reports, DMF and NDA submissions to the FDA and assisting with all Regulatory Affairs department needs as they pertain to regulatory compliance.  The Director of Regulatory Affairs will ensure timeliness of deliverables; edit/format/review regulatory documents; and work with Zynerba staff in resolving regulatory issues and/or problems and will ensure that the company adheres to all applicable regulations.

 

This position will be office-based in our Devon, Pennsylvania office.

 

Responsibilities

  • Prepare regulatory submissions (i.e, Pre-IND, IND, NDA, supplements, annual reports, IND safety reports, study protocols and study reports) to ensure compliance with the FDA and International Conference on Harmonization (ICH) guidelines.
  • Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
  • Provide regulatory assistance with Development activities, including review or authoring of essential regulatory documents and informed consent form (ICF) templates or site specific ICF.
  • Provide regulatory assistance with Manufacturing activities, including review of specifications, batch records, stability protocols, and regulatory manufacturing submission documents.
  • Develop and maintain regulatory process procedures and templates.
  • Coordinate submission of serious adverse drug reactions (ADR) to FDA, other applicable regulatory authorities working with Zynerba Clinical.
  • Participate in the project/regulatory submission team and provide clear and consistent regulatory recommendations under appropriate supervision.
  • Develop regulatory strategies (CMC, clinical and non-clinical).
  • Interface with the FDA and other regulatory agencies.
  • Keep senior management informed of all key regulatory issues.

 

Requirements

  • S. or equivalent in Life sciences, or other similar technical field and 6 to 8 years of regulatory experience with new chemical entities; Master’s degree or Regulatory Affairs Certification (RAC) is preferred.
  • Strong working knowledge of US FDA regulations and ICH guidelines.
  • Must demonstrate strong verbal and written communication skills.
  • Strong computer skills, MS Word, Excel, Outlook, MS Project and PowerPoint.

 

Apply for this Position

Apply here.