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- Tasks: Lead regulatory strategy for precision medicine and digital health across regions.
- Company: Join a pioneering company at the forefront of healthcare innovation.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Why this job: Shape the future of healthcare by uniting science and technology.
- Qualifications: Bachelor's degree in relevant fields and experience in regulatory affairs.
- Other info: Mentorship opportunities and high-visibility projects await you!
The predicted salary is between 80000 - 120000 ÂŁ per year.
You will lead regulatory strategy for precision medicine and digital health across respective regions. You will work with scientific, clinical, digital and commercial teams to design and deliver regulatory plans that enable safe, effective and compliant development. This role offers visible impact, career growth, and the chance to help unite science, technology and talent to get ahead of disease together.
Key Responsibilities- Lead development and execution of regional regulatory strategies for precision medicine and digital health assets.
- Coordinate regulatory interactions with local and regional health authorities and external partners.
- Provide regulatory input to crossâfunctional project teams from early development through lifecycle management.
- Ensure regulatory compliance for companion diagnostics, software as a medical device (SaMD), and digital health components.
- Interpret regulatory feedback and translate it into clear operational plans and submission materials.
- Mentor and coach colleagues to build regulatory capability across the business.
- Lead highâvisibility projects and grow your regulatory leadership skills, working with multidisciplinary teams and external partners to shape how new technologies reach patients.
- Bachelor's degree in biological science, healthcare science, engineering or an equivalent field.
- Experience working in the pharmaceutical industry, MedTech industry or regulatory authorities.
- Practical experience with regulation of companion diagnostics and/or SaMD.
- Proven track record leading development, submission and approval activities in one or more regions.
- Experience preparing for and leading regulatory milestone meetings and authority interactions.
Director, Regulatory Affairs, Precision Medicine & Digital Health in Stevenage employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Director, Regulatory Affairs, Precision Medicine & Digital Health in Stevenage
â¨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs space, especially those involved in precision medicine and digital health. Use platforms like LinkedIn to connect and engage with them; you never know who might have the inside scoop on job openings.
â¨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory strategies and compliance. Be ready to discuss how you've navigated regulatory challenges in the past, especially with companion diagnostics and SaMD. Show us that you can translate complex regulations into actionable plans!
â¨Tip Number 3
Donât just apply anywhere; focus on companies that align with your passion for precision medicine and digital health. Check out our website for tailored job listings that match your skills and interests. We want to help you find the perfect fit!
â¨Tip Number 4
Follow up after interviews! A simple thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show your genuine interest in the role and the company. Letâs make sure they remember you!
We think you need these skills to ace Director, Regulatory Affairs, Precision Medicine & Digital Health in Stevenage
Some tips for your application đŤĄ
Tailor Your Application: Make sure to customise your CV and cover letter for the Director role. Highlight your experience in regulatory affairs, especially in precision medicine and digital health, to show us youâre the perfect fit!
Showcase Your Achievements: Donât just list your responsibilities; we want to see your impact! Use specific examples of how you've led regulatory strategies or navigated complex submissions to demonstrate your expertise.
Be Clear and Concise: When writing your application, clarity is key. Use straightforward language and avoid jargon where possible. We appreciate a well-structured application thatâs easy to read!
Apply Through Our Website: We encourage you to apply directly through our website. Itâs the best way for us to receive your application and ensures you donât miss any important updates from our team!
How to prepare for a job interview at Gsk
â¨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations surrounding precision medicine and digital health. Familiarise yourself with the specific guidelines for companion diagnostics and software as a medical device (SaMD). This will show that youâre not just knowledgeable but also genuinely interested in the field.
â¨Showcase Your Leadership Skills
Since this role involves mentoring and leading cross-functional teams, be prepared to share examples of how you've successfully led projects or teams in the past. Highlight your experience in regulatory strategy development and how youâve navigated complex interactions with health authorities.
â¨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or feedback from health authorities. Think through potential scenarios in advance and outline your thought process for addressing them. This will demonstrate your problem-solving skills and strategic thinking.
â¨Connect with the Companyâs Vision
Research StudySmarterâs mission and values, especially how they relate to uniting science, technology, and talent. Be ready to discuss how your background and aspirations align with their goals, particularly in advancing patient care through innovative regulatory strategies.