Hybrid Manager, Global Regulatory Affairs – Oncology

Posted 6 hours ago

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About the role

  • Global Regulatory Affairs Manager at GSK responsible for developing and executing global regulatory strategies. Collaborate with cross-functional teams to ensure compliance and successful submissions.

Responsibilities

  • Proactively develop or implement regulatory strategies to ensure the submission and approval of clinical trial applications and other deliverables within agreed timescales.
  • Ensure effective interaction with cross-functional teams, global/regional counterparts, and local operating companies.
  • Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
  • Assess precedent, regulatory intelligence, and the competitive environment to inform and refine regulatory strategies.

Requirements

  • Minimum of a Bachelor’s degree in biological or healthcare science.
  • Minimum of 1 year experience in the drug development process within regulatory affairs.
  • Proven ability to manage development, submission, and approval activities in different regions globally.
  • Minimum of one year of experience in clinical trial requirements in at least one region (EU or US) and ideally familiarity with other key agency processes globally.
  • Advanced Scientific Degree (PhD, MD, PharmD) is preferred.
  • Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs is preferred.

Benefits

  • Health care and other insurance benefits (for employee and family)
  • Retirement benefits
  • Paid holidays
  • Vacation
  • Paid caregiver/parental and medical leave

Job title

Manager, Global Regulatory Affairs – Oncology

Job type

Experience level

Junior

Salary

$138,750 - $231,250 per year

Degree requirement

Bachelor's Degree

Location requirements

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