Manager, Global Regulatory Strategy - Oncology

About the Role

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

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.

Basic Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine or a related field.
• 1+ years of experience in the drug development process within regulatory affairs.
• Experience with oncology drug development, including clinical trial applications and regulatory submissions.
• Experience working in matrix teams across functions and regions.

Preferred Experience

• Advanced Scientific Degree (PhD, MD, PharmD).
• Strong matrix working skills, with the ability to facilitate dialogue and idea contribution among team members.
• Proactive problem-solving skills to identify and resolve project or team issues in advance.
• Creative regulatory problem-solving capabilities, balancing agency expectations and compliance.
• Focus on continuous improvement and excellence, with the ability to challenge current processes and recommend strategic changes.
• Ability to develop networks within GSK to secure support and achieve project outcomes.

Skills

• Business Resilience
• Communication
• Digital Fluency
• Matrix Leadership
• Pharmaceutical Regulatory Compliance
• Regulatory Strategies
• Resource Management
• Stakeholder Management

Pay

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges from $138,750 to $231,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.

Benefits

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.