At a Glance
- Tasks: Lead a team to navigate regulatory requirements and enhance market access for innovative medical products.
- Company: Join Thermo Fisher Scientific, a leader in science and inclusivity.
- Benefits: Competitive salary, career growth, and a supportive workplace culture.
- Other info: Collaborate with diverse teams and engage with healthcare providers globally.
- Why this job: Make a real impact on global health while advancing your career in a dynamic environment.
- Qualifications: Experience in regulatory affairs and strong leadership skills required.
The predicted salary is between 36000 - 60000 £ per year.
Joining Thermo Fisher Scientific means engaging in meaningful work that positively affects the world. Our colleagues bring our Mission to life daily, helping customers create a healthier, cleaner, and safer planet. We equip our global teams with resources to reach personal career objectives while advancing science through solutions addressing challenges like environmental protection, food safety, and cancer research.
Position Summary
The purpose of this role is to increase market access for Microbiology Division’s (MBD) clinical IVD products through successful pre-market licenses, renewals, and strategic market analysis. This position focuses on navigating regulatory requirements to enable global market entry through licensing and regulatory strategy. The role leads a team of nine regulatory professionals who craft submissions based on product technical data and capture vital regulatory intelligence. Key interfaces include the Global Regulatory Affairs team, Marketing, Sales, and Thermo Fisher regional RA shared services.
Responsibilities
- Regulatory Licensing and Compliance: Acquire pre-market licenses, handle renewals, and maintain license changes globally. Ensure regulatory pathways, documentation, and country-specific requirements are accurately interpreted and implemented.
- Market Access Strategy and Analysis: Perform market assessments to aid regulatory pathways and worldwide market introduction.
- Regulatory Intelligence: Acquire, assess, and communicate actionable regulatory intelligence across global teams.
- Operational Excellence: Develop and monitor key performance indicators related to licensing activities. Drive continuous improvement initiatives to reduce time‑to‑license, improve submission quality, and optimize global processes.
- External Engagement: Engage with healthcare providers and regulatory authorities to support submission discussions, clarify regulatory expectations and answer questions.
- Cross‑Functional Coordination: Collaborate with Regulatory Affairs, Marketing, Sales, Product Management and Quality on market access strategies, product compliance and lifecycle changes.
- Leadership & Team Development: Direct and mentor a team of regulatory professionals by communicating clear objectives, prioritizing tasks, and upholding accountability. Support personal development, professional progression, and a positive workplace culture.
Minimum Qualifications
- Bachelor’s/Master’s Degree or equivalent experience, diploma, or equivalent combination of qualifications in life science, engineering, legal, or related fields.
- Validated experience with international regulatory affairs within the medical device or IVD industry.
- Over 5 years of experience in regulatory affairs, including handling global submissions and market entry.
Skills
- Excellent regulatory communication and presentation skills at all organizational levels.
- Expertise in multinational regulatory strategy, risk‑benefit analysis, and collaboration with internal and external partners.
- Strong project management skills with the ability to manage complex global portfolios and prioritize competing deadlines.
- Ability to develop and engage in a high-performance team dedicated to accountability.
- Capability to lead, influence, and innovate within a cross‑functional environment.
Regulatory Affairs Manager - Market Access employer: myGwork - LGBTQ+ Business Community
Thermo Fisher Scientific is an exceptional employer that champions inclusivity and personal growth, making it a prime choice for professionals in the Regulatory Affairs field. With a commitment to meaningful work that contributes to global health and safety, employees benefit from a supportive work culture, opportunities for career advancement, and the chance to lead a dynamic team dedicated to impactful projects. Located in a vibrant environment, Thermo Fisher fosters collaboration and innovation, ensuring that every team member can thrive while making a difference.
Contact Details:
myGwork - LGBTQ+ Business Community Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager - Market Access
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like myGwork - LGBTQ+ Business Community looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Manager - Market Access
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at myGwork - LGBTQ+ Business Community. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at myGwork - LGBTQ+ Business Community
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with myGwork - LGBTQ+ Business Community’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
