Manager, Global Regulatory Strategy - Oncology

GSK; Durham (NC); On-site; USD 139,000 - 231,000; Full time

Benefits offered by this job

Health care

Retirement benefits

Paid holidays

Paid leave

Job summary

GSK in Durham, NC is seeking a Regulatory Affairs professional to drive regulatory strategy for clinical trial applications and ensure timely submissions. The role requires collaboration with cross-functional teams across regions and strong attention to compliance during the product lifecycle.

The candidate will contribute to oncology drug development and regulatory submissions, leveraging experience in matrix environments and a solid life sciences foundation.

Qualifications

• Bachelor’s degree in life sciences, pharmacy, medicine or 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.

Responsibilities

• Regulatory Strategy: Develop or implement regulatory strategies for submissions within timelines.
• Cross-functional Collaboration: Interact 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 strategies.

Skills

Bachelor's degree

1+ year experience

Oncology drug development

Matrix cross-functional teamwork

Education

Bachelor's degree in life sciences/pharmacy/medicine

Advanced Scientific Degree (PhD/MD/PharmD)

Job description

Business Introduction

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.

Find out more:

Our approach to R&D

Responsibilities include:

• 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

• 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.
• 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.

Skills

• 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.

Why GSK?

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer.

This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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