Global Regulatory Affairs Manager, Oncology

GSK plc; Durham (NC); Hybrid; USD 139.000 - 231.000; Vollzeit

Benefits dieser Stelle

Healthcare benefits

Pension plan

Share incentive program

Annual bonus

Zusammenfassung

GSK plc in the United States is seeking a Global Regulatory Affairs Manager in Oncology to lead global and regional regulatory strategies for oncology assets, ensuring robust labeling and timely approvals while upholding compliance.

You will collaborate with cross-functional teams, report to the Global Regulatory Lead and Therapeutic Area Head, and drive strategic changes across regions, aligning with Medicines Development Strategy and Integrated Asset Plans.

Qualifikationen

• Minimum: Bachelor's degree in biological, pharmaceutical or healthcare science.
• 1+ year of experience in drug development process, preferably in regulatory affairs and oncology.
• Advanced degree (PhD, MD, PharmD) preferred.
• Experience leading global/regional regulatory activities and working in oncology.

Aufgaben

• Develop and execute global/regional regulatory strategies for oncology assets.
• Ensure optimal labeling and approvals while maintaining compliance.
• Collaborate with cross-functional teams to shape development plans and regulatory interactions.
• Support interactions, reviews, and submissions with regulatory authorities.
• Drive process improvements and strategic changes across regions.

Kenntnisse

Business Resilience

Communication

Digital Fluency

Matrix Leadership

Regulatory Compliance

Regulatory Strategies

Resource Management

Stakeholder Management

Ausbildung

Bachelor's degree in biological, pharmaceutical or healthcare science

Advanced scientific degree (PhD, MD, PharmD)

Jobbeschreibung

Global Regulatory Affairs Manager, Oncology

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programs, pension plan membership, and shares and savings programme.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company-wide benefits and life at GSK on our webpage Life at GSK | GSK

Find out more about GSK and R&D: Our approach to R&D

As a Global Regulatory Affairs Manager at GSK, you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions. We value clear thinking, collaboration, practical problem solving and a patient-first mindset.

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

• Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements
• Collaborate with cross-functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan
• Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval
• Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision-making
• Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle
• Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes

Basic Qualifications:

• Minimum: Bachelor's degree in biological, pharmaceutical or healthcare science
• 1+ year of experience in drug development process, preferably in regulatory affairs and oncology

Preferred Qualifications:

• Advanced scientific degree (PhD, MD, PharmD)
• Knowledge of clinical trial and licensing requirements in at least one major regional/global market
• Proven ability in managing global and regional development, submission, and approval activities
• Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints
• Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation
• Strong written and verbal communication skills for clarity and impact
• Experience working effectively in matrix teams
• Experience working in oncology

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail]

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/