Manager, Global Regulatory Affairs (Oncology)

Role Summary

Global Regulatory Affairs Manager (Oncology) at GSK. You will develop and execute global and regional regulatory strategies for oncology assets, ensuring development programs meet key market needs and align with Medicines Profile. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area Head, ensuring timely submission and approval of clinical trial applications. Location includes USA sites in Pennsylvania (Upper Providence, Durham Blackwell Street), Maryland (Rockville), and Massachusetts (Waltham).

Responsibilities

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

Qualifications

• Required: Minimum of a Bachelor’s degree in biological or healthcare science.
• Required: Minimum of 1 year experience in the drug development process within regulatory affairs.
• Required: Proven ability to manage development, submission, and approval activities in different regions globally.
• Required: 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.
• Preferred: Advanced Scientific Degree (PhD, MD, PharmD).
• Preferred: Minimum of two years of experience in Oncology (Hematology or Solid Tumor) regulatory affairs.
• Preferred: Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Preferred: Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Preferred: Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• Preferred: A focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Preferred: Ability to develop networks within GSK to secure support and achieve project outcomes.