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)
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