Career Opportunity: Director of Regulatory Affairs

Position Summary

Zynerba Pharmaceuticals is searching for a creative, collaborative and self-motivated Director of Regulatory Affairs that will be responsible for providing strategic regulatory expertise and leadership for global and regional health authority interactions and submissions.  Responsibilities include managing communication with the United States Food and Drug Administration (FDA) and other regulatory agencies, compiling and processing Pre-IND/IND original submissions and amendments, Orphan Drug Requests, Annual Reports, DMFs and NDAs, 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.

The Director of Regulatory Affairs will report directly to the VP Regulatory Affairs and Quality Assurance.  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 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 advice for all Development activities, including review or authoring of essential regulatory documents and informed consent form (ICF) templates or site specific ICF.
  • Provide regulatory support for CMC activities including regulatory manufacturing submission documents.
  • Develop and maintain regulatory process procedures and templates.
  • Coordinate submission of IND Safety reports to FDA, and other applicable regulatory authorities as appropriate.
  • Participate in the project/regulatory submission teams and provide clear and consistent regulatory recommendations.
  • Develop regulatory strategies and provide regulatory support for all CMC, clinical and nonclinical activities.
  • Interface with the FDA and other regulatory agencies as needed.
  • Keep senior management informed of all key regulatory and quality assurance issues.

Requirements

  • B.S. or equivalent in Life sciences, or other similar technical field and 10+ years of pharmaceutical regulatory experience with new chemical entities.
  • Experience in supporting Orphan Drugs and Rare Disease medicines
  • 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.
  • This job description is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization.

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