At a Glance
- Tasks: Lead regulatory strategies and ensure compliance in the healthcare sector.
- Company: Join ICON, a global leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health coverage, and career development opportunities.
- Other info: Be part of an inclusive team that values integrity and collaboration.
- Why this job: Make a real impact on patient care by driving innovative regulatory solutions.
- Qualifications: 10-12 years in regulatory affairs with strong leadership and communication skills.
The predicted salary is between 80000 - 100000 £ per year.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Director, Regulatory Affairs at ICON, you will ensure compliance with regulatory requirements and provide strategic direction to ICON's customers both in pharma and small biotechs.
What You Will Do- Driving Strategic Development: Collaborating with internal and external teams to define and develop robust regulatory strategies, utilising Target Product Profiles (TPPs) and Clinical Development Plans (CDPs) to achieve broader development goals.
- Leading Submissions & Lifecycle Management: Directing the development, hands‑on authoring, and submission management of regulatory documents. This includes overseeing initial European Marketing Authorisation Applications (MAAs - CP, MRP, or DCP) as well as post‑licensing lifecycle management.
- Navigating European Pathways: Managing complex pre‑marketing designation submissions in Europe, with specific expertise in Orphan Drug Designations, Paediatric Investigation Plans (PIPs), and PRIME.
- Leading Agency Interactions: Leading regulatory agency interactions from the front— including Scientific Advice meetings—while coaching and training customer or internal SMEs to achieve optimal meeting objectives.
- Providing Regulatory Intelligence & Insights: Overseeing the interpretation of relevant legislation and guidelines to drive informed decision‑making and establish strong partnerships with regulatory agencies.
You will bring significant regulatory affairs experience developed across 10-12 years of industry and/or consulting roles, with a track record of working in high‑performing teams and delivering results.
Required qualifications and experience- Education: At least a Bachelor’s degree in a relevant scientific discipline or healthcare‑related field; advanced degree preferred.
- Experience: Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry, with a proven history of managing European regulatory procedures (CP/DCP) and post‑authorization activities. Candidates with advanced therapy or international market experience are particularly welcome although this is not essential.
- Strategic & Technical Ability: Deep expertise in developing regulatory strategies (TPPs, CDPs), combined with self‑sufficiency in technical document writing and submission management.
- Leadership Skill: Strong leadership skills and a proven ability to manage cross‑functional teams and complex projects in a collaborative environment.
- Communication: Excellent interpersonal, stakeholder management, and agency negotiation skills, with the ability to influence and drive change in a complex organization.
- Travel: Willingness to travel as required (approximately 25%).
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location. ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request. Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Director, Regulatory Affairs Reading employer: Meeveem Limited
ICON is an exceptional employer, offering a dynamic work environment in Reading where integrity, collaboration, and inclusion are at the forefront of our culture. As a Director in Regulatory Affairs, you will benefit from competitive salaries, comprehensive health and wellbeing programmes, and robust learning and development opportunities that empower your career growth. Join us in our mission to accelerate the delivery of new medicines and treatments, while enjoying a supportive workplace that values your contributions and fosters professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Director, Regulatory Affairs Reading
✨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 Meeveem Limited looking for candidates who are engaged and informed.
We think you need these skills to ace Director, Regulatory Affairs Reading
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 Meeveem Limited. 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 Meeveem Limited
✨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 Meeveem Limited’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
