Manager, Global Regulatory Strategy - Oncology

Posted 3 Days Ago
Be an Early Applicant
Blackwell, County Durham, England, GBR
In-Office
139K-231K Annually
Junior
Healthtech • Biotech • Pharmaceutical
The Role
Lead global regulatory strategies for oncology drug development, including clinical trial applications and regulatory submissions. Collaborate with cross-functional, regional, and local teams; maintain compliance throughout the product lifecycle; and use regulatory intelligence, precedent, and competitive insights to refine strategies. The role requires oncology development experience, matrix-team collaboration, and the ability to address regulatory and project challenges proactively.
Summary Generated by Built In

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: 

 
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.

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 - [email protected]

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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/

Skills Required

  • Bachelor's degree in life sciences, pharmacy, medicine, or a related field
  • At least 1 year 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
  • Advanced scientific degree such as PhD, MD, or PharmD
  • Strong matrix working skills and ability to facilitate dialogue and idea contribution
  • Proactive problem-solving skills
  • Creative regulatory problem-solving capabilities
  • Continuous improvement and strategic process-change skills
  • Ability to develop internal networks and secure support for project outcomes

GSK Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GSK and has not been reviewed or approved by GSK.

  • Strong & Reliable Incentives Compensation is characterized as including strong salary and perks, with annual bonuses and long-term incentives contributing materially to total rewards. Recognition and performance-linked rewards are described as a consistent component of the package.
  • Healthcare Strength Health coverage is presented as comprehensive, spanning medical, dental, vision, disability, life insurance, and mental health benefits. The breadth of coverage is repeatedly framed as a standout element of the overall rewards experience.
  • Retirement Support Retirement offerings are described as robust, anchored by a 401(k) plan and additional savings vehicles such as employee stock purchase programs. Employer contributions and savings options are portrayed as meaningful supports for long-term financial security.

GSK Insights

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The Company
HQ: Brentford
105,615 Employees
Year Founded: 2000

What We Do

A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people.

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