At a Glance
- Tasks: Lead global regulatory strategies for oncology, ensuring compliance and optimal approvals.
- Company: Join GSK, a global biopharma leader dedicated to improving health worldwide.
- Benefits: Enjoy competitive salary, bonuses, healthcare, and flexible hybrid working options.
- Other info: Collaborative culture with opportunities for innovation and professional growth.
- Why this job: Make a real impact on patient health while advancing your career in a dynamic environment.
- Qualifications: Bachelor's degree in biological sciences and experience in regulatory affairs preferred.
The predicted salary is between 138750 - 231250 £ per year.
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.
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.
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:
We are looking for professionals with these required skills to achieve our goals:
- Minimum: Bachelor’s degree in biological, pharmaceutical or healthcare science.
- 1+ year of experience in drug development process, preferably in regulatory affairs and oncology.
- 1+ years of experience in clinical trial requirements in at least one major regional/global market.
Preferred Qualifications:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
- Advanced scientific degree (PhD, MD, PharmD).
- 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.
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.
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.
Global Regulatory Affairs Manager, Oncology employer: GlaxoSmithKline plc
GSK is an exceptional employer that fosters a culture of innovation and collaboration, making it an ideal place for professionals seeking to make a meaningful impact in the biopharma industry. With a commitment to employee growth through continuous learning opportunities and a flexible hybrid working model, GSK empowers its workforce to thrive while contributing to groundbreaking advancements in healthcare. Located in vibrant London, employees benefit from a dynamic work environment that prioritises ambition for patients and accountability for results.
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We think this is how you could land Global Regulatory Affairs Manager, Oncology
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We think you need these skills to ace Global Regulatory Affairs Manager, Oncology
Some tips for your application 🫡
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