At a Glance
- Tasks: Lead global regulatory strategies for oncology assets and ensure compliance.
- Company: Join GSK, a global biopharma company with a mission to impact 2.5 billion lives.
- Benefits: Enjoy a hybrid working model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative culture focused on innovation and patient-first mindset.
- Why this job: Make a real difference in healthcare while advancing your career in a dynamic environment.
- Qualifications: Bachelor's degree in biological or healthcare science; experience in regulatory affairs preferred.
The predicted salary is between 63000 - 77000 £ per year.
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.
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:
- 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.
This role is based in GSK HQ in London UK, Stevenage UK or alternatively in Switzerland Baar Onyx. The working pattern is hybrid, combining time in the office and remote work.
We are seeking professionals with the following required skills and qualifications:
- Minimum: Bachelor's degree in biological, pharmaceutical or healthcare science.
- Proven experience in drug development process, preferably in regulatory affairs and oncology.
- Knowledge of clinical trial and licensing requirements in at least one major regional/global market.
- Strong written and verbal communication skills for clarity and impact.
- Experience working effectively in matrix teams.
If you have the following characteristics, it would be a plus:
- 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.
If this role feels like the right next step, we encourage you to apply. Please submit your CV and a brief cover letter outlining how your experience matches the role. We look forward to hearing from you.
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.
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 in London employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
StudySmarter Expert Advice🤫
We think this is how you could land Global Regulatory Affairs Manager in London
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Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Gsk. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Gsk.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Gsk is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Global Regulatory Affairs Manager in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Gsk!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Gsk that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Gsk!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Gsk, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Gsk
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Gsk that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Gsk’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
