• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Global Regulatory Strategy Lead

Job Number: 34838

Location:

Job Description

Reporting to the Head of Regulatory Strategy, the Global Regulatory Strategy Lead (GRSL) develops and implements global regulatory strategies for the Gates MRI portfolio. This role involves:

  • Developing innovative regulatory approaches with transparency and urgency.
  • Leading global regulatory affairs with experience in product development and licensure.
  • Collaborating cross-functionally on product development teams.
  • Documenting, implementing, and updating regulatory plans and Health Authority engagement plans for the portfolio's progression.

Responsibilities

  • Implement global regulatory plans for product candidates.
  • Develop regulatory strategies for different candidate modalities.
  • Lead interactions with Health Authorities and communicate outcomes.
  • Provide input on clinical trial documentation and vendor selection.
  • Ensure compliance with quality activities.
  • Prepare regulatory documentation for clinical trials and licensure.
  • Collaborate with key stakeholders for regulatory advancement.
  • Stay updated on regulatory trends and support ongoing development.

Required Skills

  • 8-10+ years of regulatory strategy experience with an advanced degree.
  • Experience in late-stage vaccine regulatory and small molecules/biologics.
  • Proficient in regulatory affairs, including submissions, IND applications, and filings.
  • Skilled in breakthrough and accelerated approval pathways.
  • Successful track record in global regulatory strategies and approvals.
  • Knowledgeable in ICH, FDA, and EMA regulations, as well as GLP, GMP, and GCP.
  • Effective management of external regulatory consultants and CROs.
  • Strong ability to address regulatory risks collaboratively and work under pressure.

 

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