At a Glance
- Tasks: Lead regulatory submissions and manage compliance for new pharmaceutical products.
- Company: Dynamic mid-sized pharmaceutical company in Berkshire with a high-performing team.
- Benefits: Competitive salary, career growth opportunities, and a chance to work on innovative products.
- Other info: Autonomous work environment with opportunities for professional development.
- Why this job: Join a pivotal role in shaping the future of healthcare with exciting new product launches.
- Qualifications: Bachelor's degree in Life Sciences and 8 years of relevant regulatory experience.
The predicted salary is between 63000 - 77000 £ per year.
I am partnering with a Mid sized Pharmaceutical client who are looking for a Regulatory Affairs Manager on a permanent basis working from their new Offices in Berkshire, the ideal person will have Health authority experience and has been involved in national route submissions.
This is a really great opportunity to be part of a high performing team and an exciting time to be joining the business with several new products coming to market
Submissions
- Leading development of MHRA regulatory documents and meetings.
- Coordination of all necessary regulatory affairs activities, in particular approval and maintenance. Project lead and manage all OPUK Regulatory activities, for example:
- Scientific Advice meetings,
- PIPs o Orphan Drug designations (ODDs).
- New Registrations via National or Centralised Procedure.
- Life-cycle management.
Implementation of EU Regulatory Strategy to maintain the organisation's existing product licences, and to integrate newly approved products into the portfolio.
- Management of overseas Affiliates and other Partners.
- preparing or authoring commercial and post approval submissions.
- representing the company in communications and meetings with health authorities.
Management
- Advising EU and UK regulatory considerations in developing strategy.
- Planning skills for: o regulatory submissions (MAAs) for products. o preparing forecasts for resource requirements o providing areas of improvement for products, processes, or services.
- Providing regulatory direction on regulatory mechanisms to optimise product registration.
- Serve as a CTD strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with minimal supervision for .
- Ensuring regulatory databases and trackers are maintained by the Regulatory team.
- Attend and manage internal and external meetings as required, to influence and drive the regulatory requirements of forward.
- Responsible for managing internal audits for the affiliate, to evaluate the compliance to local regulatory requirements, and corporate requirements.
Corporate image and Compliance
Competencies / Other Requirements
Bachelor's degree or higher in Life Sciences or technical field and around 8 years of experience in a similar role.
Autonomous and independent work, hands-on
Good knowledge of and experience in regional regulatory environment in relevant product area and development stage
Technically, you will have good working knowledge and experience of
- Registrations and Post marketing activity; CTD/Dossiers for MAAs (ideally, knowledge of all Modules 1 to 5).
- National Submissions and Centralised Procedure.
- Post marketing: Type Ia, Ib and II variations and renewals; labelling, PILs and Sm PCs.
- RTQs with EMA and MHRA.
- Practical experience in interacting with
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Regulatory Affairs Manager in Reading 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 Regulatory Affairs Manager in Reading
✨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 Regulatory Affairs Manager in Reading
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.
