Regulatory Affairs Executive
Meeveem Limited About the role
J&J Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Purpose of the role
We are seeking an assertive and confident Regulatory Affairs Executive to join our UK RA Team. The successful candidate will be responsible for helping establish and implement cost effective, results based, and professionally managed programs and innovative initiatives for the organization to advance business initiatives. You will also be responsible for integrating methods based on analyses of trends in the product lifecycle for marketing applications and supplements. Conducting sophisticated research related to labelling precedent, regulations, policies, and other topics as necessary to accurately advise on potential labelling impacts, strategies, or outcomes. As a more senior member of the team, you will be encouraged to mentor more junior colleagues in all aspects of the role.
Summary of responsibilities
- Management of the regulatory activities in line with the existing processes to ensure compliance with regulatory requirements and an inspection ready culture.
- Develop or contribute to local regulatory strategy in line with the applicable regulatory requirements.
- Responsible for specific therapeutic area activities, including but not limited to handling the agency submissions and questions, including cross‑functional team attendance as required.
- Cross portfolio technical and administrative activities as required.
Key role activities
- Partner with Reg Manager and allocated cross‑functional team to provide RA strategic and technical expertise and support for submissions and HA interactions.
- Prepare and submit new MAA, ILAP IP, TDP and UK PIPs and other local submissions as assigned.
- Review and approve regulatory variation documentation.
- Monitor deadlines for different projects to ensure they are met or escalated to a Regulatory Affairs manager and/or Head of RA.
- Responsible for the content of the local labelling documents released to prescribers and patients.
- Prepare and distribute local labelling documents within stipulated timelines following receipt of relevant approvals.
- Implement Risk Management Plans and, when required, coordinate a cross‑functional team to implement/update Risk Management Educational Material.
- Deputise for Regulatory Affairs Manager when required.
Compliance
- Complete activities to ensure compliance with all regulatory requirements.
- Develop and maintain in‑depth knowledge of regulations/legislation.
- Support collection of RA competitive intelligence as required.
- Subject‑matter expert on given topic and author of relevant SOPs, assuring timely execution and compliance.
Internal/External contacts
- Support other departments based on their needs by providing documentation and information in response to requests.
- Proactively share key regulatory insights with business to help shape brand strategy.
- Contact local health authorities to resolve general queries (some product specific) when these cannot be addressed internally, ensuring a positive interaction in any communication.
Miscellaneous
- Undertake, support and contribute to initiatives as requested by Head of RA.
- Contribute to initiatives around lessons learnt and change management to ensure efficiency gains.
- Actively contribute to growing the regulatory expertise of the team by mentoring junior regulatory colleagues.
By joining Johnson & Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our commitment to be the world’s healthiest workforce you can strengthen your body as well as your mind.
What’s in it for you? It’s important to us that you feel you can bring your whole self to work; at Johnson & Johnson we provide an environment for you to fulfil your career aspirations as well as promoting your physical and mental wellbeing. As part of our offering, you will receive a competitive compensation and benefits package as well as benefits that can be tailored to what’s valuable to you throughout different stages of your life.
Required Skills: Licensing Compliance, Pharmaceutical Regulatory Affairs, Regulatory Affairs Compliance.
Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking.
Your tasks
Join our team to manage regulatory activities and ensure compliance in innovative medicine.
Your profile
Experience in regulatory affairs and strong analytical skills are essential.
What's also included
Enjoy competitive pay, tailored benefits, and support for your wellbeing.
Tech stack & ways of working
Regulatory Affairs Executive employer: Meeveem Limited
Meeveem Limited is an exceptional employer that values its employees by fostering a collaborative and innovative work culture in the heart of Yorkshire. With a strong focus on professional development, employees are encouraged to grow their skills and advance their careers while enjoying competitive benefits and a supportive environment that prioritises work-life balance. Joining Meeveem means being part of a dynamic team dedicated to making a meaningful impact in the cardiovascular and endovascular sectors.
Your perspectives
Make a real impact on patients' lives while developing your career in a supportive environment.
StudySmarter Expert Advice
Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Meeveem Limited. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Meeveem Limited.
Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Meeveem Limited. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Meeveem Limited is looking for. A tailored application can really make you stand out!
Some tips for your application 🫡
Showcase Your Relevant Experience
When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Meeveem Limited!
Emphasise Your Understanding of Regulations
The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Meeveem Limited that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven
Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Meeveem Limited!
Convey Your Passion for the Industry
In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Meeveem Limited, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Meeveem Limited
Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Meeveem Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
Know Their Products
Take some time to familiarise yourself with Meeveem Limited’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
