At a Glance
- Tasks: Lead global regulatory strategies to ensure safe and effective treatments reach patients worldwide.
- Company: Join GSK, a global biopharma company dedicated to improving lives through innovative medicines.
- Benefits: Competitive salary, bonuses, health benefits, retirement plans, and generous leave policies.
- Why this job: Make a real impact in global healthcare and shape the future of medicine.
- Qualifications: Bachelor’s degree in Biological or Healthcare Science with extensive regulatory affairs experience.
- Other info: Flexible working culture with opportunities for career growth and development.
The predicted salary is between 120000 - 200000 £ per year.
Are you passionate about making a difference in global healthcare? At GSK, we are dedicated to improving lives by delivering innovative medicines and vaccines. As a Director of Regulatory Affairs, you will play a pivotal role in shaping regulatory strategies that ensure the availability of safe and effective treatments worldwide. Join us and be part of a team committed to creating healthier communities.
Job Purpose
Accountable to GRL and Global Regulatory TA Head, the Director of Regulatory Affairs will lead the development of regional / global regulatory strategies and their execution for assigned asset(s) aligned with the overall Medicines Development Strategy. Planning will be on a multiple year horizon, with delivery requiring extensive matrix leadership within GSK to VP level and representing GSK with local regulatory agency. This role works closely with local / regional commercial teams to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities.
Key Responsibilities
- Ensure the regulatory strategy will deliver the needs of the local region(s), considering the needs of other regions globally.
- Implement the regional strategy(s) in support of the project globally.
- Lead regulatory interactions and the review processes in local region.
- Ensure appropriate interaction with regional commercial teams in local region.
- Ensure compliance with regional requirements at all stages of product life.
- Advocate persuasive approaches to senior leaders in GSK and in Health Authorities.
- Capable of providing assessment of potential in license molecules.
Why You?
Basic Qualifications
- Bachelor’s degree in Biological or Healthcare Science, with previous experience in similar strategic international regulatory affairs positions.
- Extensive Experience in regulatory affairs across all phases of drug development.
- Proven track record in leading regional development, submission, and approval activities.
- Experience working on clinical trial and licensing requirements in major countries.
Preferred Qualifications
- PhD in Biological or Healthcare Science.
- Experience with projects involving little or no precedence in regulatory affairs.
- Expertise in developing product or therapeutic knowledge in new areas.
- Familiarity with digitalization in regulatory strategy to enhance decision-making and innovation.
- Proven ability to deliver creative solutions to regulatory challenges while ensuring compliance.
- Exceptional communication and leadership skills, with the ability to build strong networks and influence stakeholders.
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.
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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive.
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/.
Director employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director
✨Tip Number 1
Network like a pro! Reach out to connections in the industry, attend relevant events, and don’t be shy about asking for informational interviews. The more people you know, the better your chances of landing that Director role.
✨Tip Number 2
Prepare for those interviews! Research GSK’s recent projects and regulatory strategies. Show us you’re not just a fit for the role but also passionate about our mission to improve global healthcare.
✨Tip Number 3
Practice your pitch! Be ready to articulate your experience in regulatory affairs and how it aligns with GSK’s goals. We want to hear how you can lead and influence stakeholders effectively.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re genuinely interested in being part of our team at GSK.
We think you need these skills to ace Director
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Director role. Highlight your experience in regulatory affairs and how it aligns with GSK's mission to improve global healthcare. We want to see how you can make a difference!
Showcase Your Leadership Skills: As a Director, you'll need to lead teams and influence stakeholders. Use your application to demonstrate your leadership experience and any successful projects you've managed. We love seeing examples of how you've made an impact!
Be Clear and Concise: Keep your application straightforward and to the point. Use clear language to describe your qualifications and experiences. We appreciate when candidates can communicate effectively, just like we do at GSK!
Apply Through Our Website: Don't forget to submit your application through our official website! It’s the best way to ensure your application gets seen by the right people. We’re excited to hear from you and see how you can contribute to our team!
How to prepare for a job interview at Gsk
✨Know Your Regulatory Stuff
Make sure you brush up on the latest trends and regulations in global healthcare. Familiarise yourself with GSK's therapeutic areas and how they align with regulatory strategies. This will show your passion and expertise during the interview.
✨Showcase Your Leadership Skills
As a Director, you'll need to demonstrate your ability to lead cross-functional teams. Prepare examples of how you've successfully influenced stakeholders and navigated complex regulatory environments. Highlight your experience in matrix leadership to impress the interviewers.
✨Prepare for Scenario Questions
Expect questions that ask how you'd handle specific regulatory challenges. Think about past experiences where you delivered creative solutions while ensuring compliance. Practising these scenarios will help you articulate your thought process clearly.
✨Engage with the Interviewers
Don't just answer questions—engage in a dialogue! Ask insightful questions about GSK's current projects and future directions in regulatory affairs. This shows your genuine interest in the role and helps you build rapport with the interview panel.