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Director, Regulatory Affairs – Orphans, PIPs REF: 1007

This is an opening for a senior level regulatory professional, joining an established team in one of G&L’s largest clients; a cutting edge biopharma with an enviable pipeline.

Responsibilities:

  1. Develop and implement US and global regulatory strategy in regards to clinical development for assigned projects.
  2. Lead global and/or regional regulatory teams on assigned projects.
  3. Develop and execute US regulatory strategy for clinical development and contingencies for assigned projects.
  4. Serve as the primary interface for FDA on assigned projects.
  5. Communicate project regulatory strategies and plans to management, cross functional teams and any partners/collaborators to establish alignment.
  6. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, Breakthrough Designation, Pediatric Study Plans, PPSRs, Fast Track Designation and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
  7. Prepare company team for FDA and other health agency meetings, as required.
  8. Serve as the primary interface with Regulatory CROs or local regulatory teams globally for coordination and preparation of submissions.
  9. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
  10. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
  11. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  12. Participates in Business Development efforts, as assigned.

 

The ideal candidate will have the following:

  • Experience in multiple phases of development in various therapeutic areas.
  • Experience in inflammatory and immune diseases a plus.
  • Global experience desired.
  • Knowledge of the drug development process and global submission process.
  • Demonstrated experience in preparing FDA submissions.
  • Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
  • Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
  • Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
  • Contract Type:

    Contract opportunity

  • Location:

    NJ or CA, USA

  • Duration:

    12 months +

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