At a Glance
- Tasks: Manage regulatory compliance and post-approval activities in a dynamic pharmaceutical environment.
- Company: Growing generic pharmaceutical company with a focus on innovation.
- Benefits: Competitive salary, professional development, and a collaborative work culture.
- Other info: Onsite role with opportunities for career advancement.
- Why this job: Join a team making a real impact in the pharmaceutical industry.
- Qualifications: Pharmacy/Chemistry degree and 7-10 years of Regulatory Affairs experience required.
The predicted salary is between 55000 - 70000 £ per year.
An exciting opportunity for an experienced Regulatory Affairs Manager to take on a new role in a growing generic pharmaceutical company working towards a portfolio of 220 licenses.
Please note that this role will be onsite 5 days per week.
Responsibilities:
- Primarily responsible for post-approval and compliance activities with a support role for the pre-approval team.
- Have an excellent understanding of and be able to execute activities related to the following key areas:
- Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions.
- Reclassification of Medicines.
- Re-baseline / Remediation dossiers.
- License Transfers (giving away and bringing in) including the due diligence of dossiers.
- Maintenance of Marketing Authorisations including renewals.
- Deficiency responses to authorities.
- Interfacing with regulatory authorities to facilitate the approval of submissions.
- Work with sites (manufacturing, PV service provider)/appropriate personnel/departments to ensure regulatory requirements are met and resolve any outstanding regulatory issues.
- Act as the primary contact point for Regulatory Affairs with the business units, customers, and other internal/external teams.
- Stay informed about new and changing regulatory requirements and ensuring compliance.
- Work with QPPV on PSUR submissions, update SmPC and labelling in line with the Company Core Data sheets.
- Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
- Maintain up-to-date records and documentation in relation to Marketing Authorisations.
- Carry out duties in line with regulatory, commercial, quality and business needs and ensuring compliance with regulatory legislation and guidelines, and company processes and procedures.
- Support other regulatory staff members within the Company when necessary.
- Assist in preparation of procedures (SOPs) for relevant regulatory activities, and in preparation and review of procedures for other areas.
- Any other task given to you by relevant stakeholder in order for you to be able to perform your role.
Required Skills:
- Pharmacy/Chemistry degree.
- 7-10 years Regulatory Affairs experience.
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
- Experience with Generic products and MRP/DCP submissions is advantageous.
- Clear understanding and ability to manage:
- National Procedure (MHRA).
- MRP, DCP – Preferable.
- Any other regulatory body submissions – Added advantage.
- Usage of Submission Gateways and Tools:
- MHRA Portal.
- Eudralink.
- CESP.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
Regulatory Affairs Manager in Reading employer: Select Pharma Recruitment
Join a dynamic and innovative generic pharmaceutical company that prioritises employee development and fosters a collaborative work culture. As a Regulatory Affairs Manager, you will benefit from a supportive environment that encourages professional growth, while being part of a team dedicated to ensuring compliance and excellence in regulatory practices. Located onsite, you will enjoy the advantages of direct engagement with colleagues and stakeholders, enhancing your impact on the company's mission to expand its portfolio of licenses.
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 Select Pharma 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 Select Pharma Recruitment.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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 Select Pharma 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.
