At a Glance
- Tasks: Lead regulatory activities and ensure compliance for a diverse pharmaceutical portfolio.
- Company: Dynamic pharmaceutical company with a focus on innovation and compliance.
- Benefits: Competitive salary, career development opportunities, and a collaborative work environment.
- Other info: Join a global team and drive continuous improvement in regulatory processes.
- Why this job: Make a real impact in the pharmaceutical industry while leading a high-performing team.
- Qualifications: Degree in Life Sciences and 7 years of Regulatory Affairs experience.
The predicted salary is between 63000 - 77000 £ per year.
We are seeking an experienced Regulatory Affairs Manager to lead regulatory activities across our UK affiliate. This is an exciting opportunity to play a pivotal role in ensuring regulatory compliance, driving regulatory strategy, and supporting the lifecycle management of a diverse pharmaceutical portfolio. Working closely with UK, European and Global stakeholders, you will provide expert regulatory leadership, manage a high-performing Regulatory Affairs team, and represent the organisation in interactions with the MHRA and other regulatory authorities.
Key Responsibilities
- Lead UK regulatory activities for marketed products, including regulatory strategy, submissions, approvals and lifecycle management.
- Manage preparation, review and submission of regulatory documentation, including CTD dossiers and post-authorisation activities.
- Lead regulatory projects including new registrations, variations, renewals, Scientific Advice meetings, PIPs and Orphan Drug Designations.
- Provide regulatory input into product development strategies and support EU/UK regulatory planning.
- Represent Regulatory Affairs in cross-functional teams and provide expert advice on regulatory requirements and risks.
- Manage interactions with the MHRA, including responses to regulatory questions and meetings.
- Ensure regulatory databases, trackers, SOPs and controlled documents are maintained and compliant.
- Support labelling activities, including SmPCs, PILs and product information updates.
- Drive continuous improvement of regulatory processes and support audit readiness.
Essential Experience & Skills
- Degree in Life Sciences or a related scientific discipline.
- Approximately 7 years’ experience in Regulatory Affairs within the pharmaceutical industry.
- Experience with CTD documentation, MAAs, national and centralised procedures.
- Strong understanding of post-marketing activities.
- Experience interacting with the MHRA and managing regulatory authority responses.
- Knowledge of SmPCs, PILs, labelling requirements and regulatory compliance processes.
- Strong project management, organisational and stakeholder management skills.
- Ability to influence cross-functional teams and work effectively in a global environment.
- Experience writing SOPs, improving processes and maintaining regulatory compliance.
Senior Regulatory Specialist in Windsor employer: Parkside Recruitment
Parkside Recruitment is an excellent employer that values its employees by fostering a supportive and dynamic work culture in Ruislip. With opportunities for professional growth and development, the company encourages a proactive approach to work, ensuring that every team member feels valued and empowered. The unique blend of a fast-paced environment and a focus on employee well-being makes it a rewarding place to build your career.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Specialist in Windsor
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Parkside Recruitment. 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 Parkside Recruitment.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Parkside Recruitment. 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 Parkside Recruitment is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Regulatory Specialist in Windsor
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 Parkside Recruitment!
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 Parkside Recruitment 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 Parkside Recruitment!
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 Parkside Recruitment, 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 Parkside Recruitment
✨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 Parkside Recruitment 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 Parkside Recruitment’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.
