At a Glance
- Tasks: Manage regulatory procedures for EU and UK products, ensuring compliance and timely approvals.
- Company: Leading pharmaceutical company focused on innovation and compliance.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Collaborative environment with strong career advancement potential.
- Why this job: Join a dynamic team and make a real impact in the healthcare industry.
- Qualifications: Degree in a scientific discipline and 5-10 years of regulatory experience.
The predicted salary is between 55000 - 65000 £ per year.
Role Overview:
Manage all required regulatory procedures for EU and UK products, including both internally developed and in-licensed products. Define appropriate regulatory strategies for submission and approval of new products in the EU and UK, providing guidance to R&D during development. Ensure post-marketing lifecycle management, including identification and submission of variations following Marketing Authorisation (MA) approvals. Oversee regulatory activities for Drug–Device Combinations and Medical Devices in line with EU MDR requirements, including submissions to and approvals from Notified Bodies. Liaise effectively with EU Regulatory Authorities and the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure timely approvals, product launches, and ongoing compliance with regulatory and business requirements. Ensure EU and UK product labelling is compliant and aligned with MA approvals. Develop and implement procedures and processes to maintain regulatory compliance across the EU and UK product portfolio.
Key Responsibilities:
- Regulatory Strategy & Submissions (35%)
- Act as the regulatory expert to define and execute strategies for submission of registration dossiers in the EU and UK.
- Maximise the likelihood of rapid Marketing Authorisation approvals.
- Collaborate closely with global teams (e.g. India-based functions).
- Lead Scientific Advice activities with regulatory agencies where appropriate.
- Provide guidance to R&D, including reference product identification.
- Define and manage variation strategies to ensure business continuity.
- Support and manage in-licensed product activities.
- Dossier Preparation & Lifecycle Management (20%)
- Prepare Module 1 (M1) and manage submission of new product applications, post-approval variations and notifications.
- Coordinate product information and labelling, including leaflet and artwork development.
- Medical Devices & EU MDR Compliance (20%)
- Ensure full compliance with EU Medical Device Regulation (MDR) requirements.
- Manage regulatory activities for medical devices and drug–device combination products.
- Regulatory Authority Engagement (10%)
- Build and maintain strong relationships with EU and UK regulatory authorities.
- Lead communications via meetings, correspondence, and teleconferences.
- Prepare responses to regulatory queries and deficiency letters.
- Develop briefing documents and support materials for agency interactions.
- Compliance & Systems (5%)
- Ensure adherence to internal SOPs.
- Maintain regulatory trackers, databases, and documentation systems.
- Cross-Functional Collaboration (10%)
- Work closely with Commercial and other internal stakeholders.
- Provide regulatory input, identify opportunities, and communicate risks.
Key Interfaces:
External: EU Regulatory Authorities and the Medicines and Healthcare products Regulatory Agency (MHRA), Notified Bodies, Trade Associations, Customers’ and suppliers’ regulatory departments, Regulatory consultants.
Internal: Regulatory Affairs teams (EU and global), Research & Development, Business Development, Project Management, Pharmacovigilance / Quality Assurance / Supply Chain / Manufacturing, Analytical and Technical teams, Commercial teams.
Work Generation: Self-generated: 70%, Manager-led: 15%, Peer-driven: 15%.
Skills & Experience:
Education: Degree in a scientific discipline (essential), Additional regulatory qualifications (desirable).
Experience: 5–10 years’ experience in Regulatory Affairs within the pharmaceutical industry, Strong knowledge of EU and UK regulatory frameworks and EU MDR, Experience within a generic pharmaceutical environment, Familiarity with decentralised, mutual recognition, and national procedures.
Skills: Broad understanding of regulatory requirements across multiple markets, Experience with electronic submission systems (eCTD), Strong project management and organisational skills, Proficiency with regulatory IT systems.
Personal Attributes: High attention to detail and strong organisational skills, Effective written and verbal communication, Ability to influence and collaborate across teams, Analytical thinking and problem-solving capability, Fluent in English; additional languages are advantageous.
Regulatory Affairs Manager in Watford employer: Meet Life Sciences
As a Regulatory Affairs Manager at our company, you will thrive in a dynamic and supportive work environment that prioritises employee growth and development. We offer competitive benefits, a collaborative culture, and the opportunity to engage with leading regulatory authorities in the EU and UK, ensuring your contributions have a meaningful impact on product compliance and patient safety. Join us in our commitment to innovation and excellence in the pharmaceutical industry, where your expertise will be valued and rewarded.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Manager in Watford
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be when it comes to landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU and UK regulatory frameworks. We recommend practising common interview questions related to regulatory strategies and compliance, so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We suggest mentioning something specific from your conversation to make it more personal.
✨Tip Number 4
Apply through our website for the best chance at landing a role with us. We’re always on the lookout for passionate individuals who can help us navigate the complex world of regulatory affairs!
We think you need these skills to ace Regulatory Affairs Manager in Watford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Manager role. Highlight your experience in managing regulatory procedures and your knowledge of EU and UK frameworks. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can benefit us at StudySmarter. Don’t forget to mention any specific experiences that relate to the job description.
Showcase Your Achievements:When detailing your experience, focus on your achievements rather than just responsibilities. Did you lead a successful submission that resulted in rapid approvals? We love to see quantifiable results that demonstrate your impact!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining the StudySmarter team!
How to prepare for a job interview at Meet Life Sciences
✨Know Your Regulatory Stuff
Make sure you brush up on the EU and UK regulatory frameworks, especially the EU MDR. Be ready to discuss specific examples from your experience that demonstrate your understanding of these regulations and how you've successfully navigated them in past roles.
✨Showcase Your Strategic Thinking
Prepare to talk about how you've defined and executed regulatory strategies in previous positions. Think of a couple of key projects where your strategic input led to successful submissions or approvals, and be ready to explain your thought process.
✨Engage with Real Scenarios
Expect scenario-based questions where you'll need to demonstrate your problem-solving skills. Consider potential challenges in regulatory submissions or compliance issues and how you would address them. This shows your analytical thinking and ability to collaborate across teams.
✨Build Rapport with the Interviewers
Since this role involves liaising with regulatory authorities, practice your communication skills. Be personable and engaging during the interview. Show that you can build strong relationships, as this will be crucial in your role as a Regulatory Affairs Manager.
