Overview

The Associate Director, Regulatory Affairs is responsible for developing key regulatory strategies and executing submissions while monitoring and assessing global regulations including GT guidance and regulation changes.

Work Model:
Flex: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager

Remote: officially documented as working full time from home, with travel to the company’s offices or other locations on occasion as needed

Responsibilities:

  • Interfaces with regulatory agencies as appropriate on select programs.
  • Independently researches options for regulatory strategies and presents recommendations at core teams and to leadership.
  • Represent Regulatory in Program Team and sub-team meetings, serving as the point of contact for the assigned products, and interfacing with functional areas including Research, Development, and Clinical in strategic development for early and late-stage products.
  • Provide regulatory guidance and input throughout product development to the program team.
  • Lead cross-functional teams in Regulatory Filings (e.g. INDs, BLAs, CTAs, GMOs, MAAs)
  • Lead select Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects
  • Maintain INDs/CTAs ensuring Agency compliance
  • Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages, and General Investigational Plans to ensure GCP and Agency compliance
  • Lead teams in the development of briefing documents for Agency meetings
  • Manage and direct contractors/vendors as needed on programs
  • Keep current with Agency guidelines and regulations
  • Prepare comments on draft documentation sent out for consultation from the health authority
  • Contribute to the creation of local labels as needed
  • Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents

Requirements:

  • BA/BS in a scientific field of study or BA/BS in another field of study and –7 – 9 years of relevant experience working in Regulatory in the pharmaceutical/ biotech industry
  • Strong knowledge and experience in interpretation of regulations and guidelines related to drug development
  • In-depth understanding and application of industry standards and international regulations and guidelines.
  • Experience in communicating regulatory strategy, submission documents and plans both internally and externally

The following are some highlighted benefits, but not limited to:

  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs