At a Glance
- Tasks: Ensure compliance of pharmaceutical products and manage regulatory documentation.
- Company: Join a leading pharmaceutical company dedicated to safety and efficacy.
- Benefits: Full-time role with competitive salary and opportunities for professional growth.
- Other info: Collaborative environment with strong focus on team work and project management.
- Why this job: Make a real difference in healthcare by ensuring product safety and compliance.
- Qualifications: Degree in Life Sciences, Languages or Law; 2-5 years pharma experience required.
The predicted salary is between 51750 - 63250 £ per year.
The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products.
The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation.
He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.
Responsibilities
- Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e. g. internally with R&D, RA and artwork departments, externally with translation services and consultants for e. g.
Package Leaflet User test reports.
- Is responsible for the preparation of Sm PC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
- Is responsible for text verification of the product information documents.
- Is responsible for proof reading of artwork of packaging materials.
- Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications.
- Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
- Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
- Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
- Maintains RA archives (electronically).
- Keeps the Regulatory Information correct and accessible for other stakeholders.
- Being able to work with the required IT standards, like e CTD, XEVMPD.
- Being able to work with the corporate IT systems like AMS, Trackwise, e DMS, e LMS, One HR.
- Determines and writes standard operating procedures.
Qualifications
- Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
- 2-5 years of experience in pharma
- Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
- Some understanding of the drug development process
- Able to comply with company standard operating procedures
- Good verbal and written communication skills in English
- Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as e CTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
- Excellent attention to detail
- Good organization and project management skills
- Good interpersonal and team working skills
- Presentation skills and experience of delivering training
- Seniority Level
- Associate
- Employment Type
- Full-time
- Job Function
- Other
- Industries
- Pharmaceutical Manufacturing and Retail Pharmacies
- #J-18808-Ljbffr
Regulatory Affairs Officer employer: SUN PHARMA
At SUN PHARMA, we pride ourselves on being an excellent employer that fosters a collaborative and innovative work culture. Located near Heathrow, our team enjoys access to a vibrant professional network and opportunities for personal growth through continuous learning and development. We offer competitive benefits and a commitment to making a meaningful impact in the healthcare sector, particularly in oncology and dermatology.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Officer
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like SUN PHARMA. 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 SUN PHARMA.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like SUN PHARMA. 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 SUN PHARMA is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Officer
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 SUN PHARMA!
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 SUN PHARMA 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 SUN PHARMA!
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 SUN PHARMA, 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 SUN PHARMA
✨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 SUN PHARMA 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 SUN PHARMA’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.
