Director, Global Regulatory Affairs (Oncology)

Company: GlaxoSmithKline
Location: Rockville
Posted on: May 3, 2025

Job Description:

Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Rockville Vaccines, WalthamPosted Date: Feb 4 2025At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.Are you passionate about regulatory strategy and oncology? We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global and regional regulatory strategies for assigned assets in our growing oncology portfolio. Your efforts will ensure compliance with regulatory requirements while optimising the development programme to meet the needs of patients in global markets.In this role you will

• Act as the Global Regulatory Lead (GRL), or collaborate as a regional lead with the GRL, and Global Regulatory Therapeutic Area (TA) Head to develop and implement robust regional regulatory strategies.
• Engage in extensive matrix working within GSK, including with senior management, and represent GSK with local regulatory agencies.
• Work closely with global and regional counterparts, as well as local commercial teams, to ensure a harmonized approach to regulatory submissions and approvals.
• Maintain compliance with global and regional regulatory requirements throughout the product lifecycle.
• Conduct regulatory intelligence activities to assess the competitive landscape and its impact on regulatory strategies.Basic Qualifications & Skills:
  • Bachelor's degree in biological or healthcare science
  • Minimum of 5+ years of experience in pharmaceutical industry Regulatory Affairs
  • Minimum of 2 years of experience in Oncology
  • Capable of leading development, submission and approval activities in different regions globallyPreferred Qualifications & Skills:
    • Advanced Scientific Degree (PhD, MD, PharmD).
    • Experience with all phases of the drug development process in regulatory affairs.
    • Awareness of global regulatory processes, including submission and approval activities.
    • Strong matrix working skills with the ability to facilitate dialogue and contribute to strategic changes.
    • Creative problem-solving abilities with a balanced approach to regulatory expectations and compliance.The annual base salary for new hires in this position ranges from $166,500 to $277,500. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together. Our success absolutely depends on our people. If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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