Responsibilities include:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Why You?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• 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

If you have the following characteristics, it would be a plus:

• 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.

• A 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.

#GSK-LI

Skills
Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management
• 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 $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. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

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