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: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with excellent career advancement opportunities.
- Why this job: Make a real impact in the healthcare industry while working with innovative products.
- Qualifications: Degree in Life Sciences, Languages or Law; 2-5 years pharma experience required.
The predicted salary is between 36000 - 60000 £ 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 the 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 SmPC, 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 eCTD, XEVMPD.
- Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR.
- 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 eCTD 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
Regulatory Affairs Officer in England 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 in England
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory challenges and be ready to discuss how your skills can help them navigate these issues. Show them you’re not just another candidate!
✨Tip Number 3
Practice your communication skills! As a Regulatory Affairs Officer, you'll need to liaise with various teams. Mock interviews with friends or mentors can help you articulate your thoughts clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Regulatory Affairs Officer in England
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Regulatory Affairs Officer role. Highlight your relevant experience in pharma and any specific knowledge of UK and EU regulations. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how your skills can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Attention to Detail:Given the nature of the role, attention to detail is crucial. In your application, provide examples of how you've demonstrated this skill in previous positions. We want to know you can handle the nitty-gritty!
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts and you’re good to go!
How to prepare for a job interview at SUN PHARMA
✨Know Your Regulations
Make sure you brush up on the UK and EU regulatory frameworks. Familiarise yourself with key directives, regulations, and guidelines that are relevant to the pharmaceutical industry. This knowledge will not only help you answer questions confidently but also demonstrate your commitment to the role.
✨Showcase Your Communication Skills
As a Regulatory Affairs Officer, you'll need to liaise with various departments and external partners. Prepare examples of how you've effectively communicated complex information in the past. Practising clear and concise explanations will help you shine during the interview.
✨Demonstrate Attention to Detail
Given the nature of the role, attention to detail is crucial. Bring along examples of documents or projects where your meticulousness made a difference. Highlighting your proofreading skills and ability to manage technical content will set you apart from other candidates.
✨Familiarise Yourself with IT Systems
Since the job requires working with specific IT standards and corporate systems, make sure you're comfortable discussing your experience with tools like eCTD and XEVMPD software. If you have any experience with AMS, Trackwise, or similar systems, be ready to share how you've used them effectively.
