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For Companies At a Glance
- Tasks: Ensure compliance of clinical safety information and coordinate regulatory processes for Centralised Products.
- Company: Join Accord Healthcare, a fast-growing pharmaceutical company making a global impact.
- Benefits: Competitive salary, bonus, holiday, pension scheme, and opportunities for personal growth.
- Why this job: Make a real difference in healthcare while working in a dynamic and progressive environment.
- Qualifications: Life Science degree and experience in regulatory affairs within the pharmaceutical industry.
- Other info: Be part of a team that values innovation and offers tailored training for your career growth.
The predicted salary is between 28800 - 48000 £ per year.
Overview
Regulatory Affairs Officer – Centralised Products. Role: Full-time, Permanent. Location: Stockley Park. Salary: Competitive + Bonus.
The Role
We have a new and exciting opportunity within our Scientific Affairs team for a Regulatory Affairs Officer (Safety Information). This role will provide essential regulatory support to ensure clinical safety particulars of Accord Marketing Authorisations within EMENA remain compliant with current legislation and Authority requests. You will coordinate and improve the process of Renewals & Safety variations for Centralized Authorized Products (CAPs), as well as other associated activities (e.g. coordinate the Reference Product Comparison activity). The role will see you collaborate with Pharmacovigilance, Quality, Regulatory Strategy, Intellectual Property, Artwork, Medical team and Submission teams on safety labelling updates, and coordinate with EU – Local Regulatory Affiliates. Candidates with extensive experience in leading Centralised Procedures and navigating complex regulatory strategies within the EU framework will be strongly preferred.
Responsibilities
- Oversee submission planning and review the submission documentation for CP
- Oversee the specific monthly metrics for EMENA region
- Ensure Local Regulatory Affiliates have the local QMS aligned with SOPs
- Oversee EU regulatory agreements
- Act as Vice-Chair of EMENA Safety Information Committee – organize, prepare the agenda and propose new topics to ensure Safety Information Compliance for CP products
- Maintain compliance with EU guidelines and regulatory requirements as well as with internal SOPs
- Collaborates with AW team for implementation of SVs for EU-CPs
- Meet all compliance timelines when performing regulatory activities
- Maintain regulatory documentation, spreadsheets and databases and regional regulatory standard operating procedures (SOPs)
- Carry out regulatory training activities within and outside the Department
The Person
- Life Science degree ideally to post-graduate degree level e.g. MSc, PhD, MD, PharmD
- Demonstrable experience in a regulatory function within the pharmaceutical industry or a senior healthcare role
- Proven experience and successful track record in relevant EU pharmaceutical regulatory legislation
- The role requires a high level of autonomy and therefore is best suited for candidates with significant prior experience in centralised procedures and EMA interactions
- Ability to navigate organizational complexity effectively
- Technical Knowledge in Microsoft Office: Word, Excel, PowerPoint
- Fluent in English, both written and spoken
- Excellent inter-personal skills, communication, influencing and problem-solving skills
- Flexibility in line with changing priorities
- Proactive approach to problem solving, meticulous attention to detail and a proven team player
The Rewards
In return, we offer a competitive salary and rewards package (including holiday, bonus and pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.
How to Apply
If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please complete your Candidate Profile on our careers site to apply for this role. The closing date is 26/08/25. For more information, you can contact us on: careers@accord-healthcare.com
About us
Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients\’ access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.
To continue our growth, we\\\’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual\\\’s focus. So, if you\\\’re looking for an inclusive company to take your career to the next level, you\\\’re certainly in the right place; come and join us to make it better.
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All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
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Regulatory Affairs Officer employer: Accord Healthcare
Contact Detail:
Accord Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already working at Accord. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of EU regulatory frameworks. Show us you know your stuff and can navigate the complexities of the role with ease!
✨Tip Number 3
Don’t just focus on your qualifications; highlight your soft skills too! Communication and problem-solving are key in this role, so be ready to share examples of how you've used these skills in the past.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows us you’re genuinely interested in joining our team at Accord.
We think you need these skills to ace Regulatory Affairs Officer
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 regulatory functions and any specific achievements that align with the job description. We want to see how your background fits perfectly 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 this role and how your skills can contribute to our team. Be sure to mention your experience with EU regulatory legislation, as it’s a key part of the job.
Showcase Your Technical Skills: Don’t forget to highlight your technical knowledge, especially in Microsoft Office tools like Word, Excel, and PowerPoint. We love candidates who can demonstrate their proficiency in these areas, as they are essential for the role.
Apply Through Our Website: We encourage you to apply through our careers site. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to complete your Candidate Profile there!
How to prepare for a job interview at Accord Healthcare
✨Know Your Regulatory Stuff
Make sure you brush up on the latest EU pharmaceutical regulations and guidelines. Familiarise yourself with the Centralised Procedures and how they impact safety information. This will show that you're not just a candidate, but someone who understands the landscape.
✨Showcase Your Collaboration Skills
Since this role involves working with various teams like Pharmacovigilance and Quality, be ready to discuss your experience in cross-functional collaboration. Prepare examples of how you've successfully worked with different departments to achieve compliance or improve processes.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Think about past challenges you've faced in regulatory affairs and how you navigated them. This will demonstrate your ability to handle the complexities of the role.
✨Highlight Your Attention to Detail
Given the meticulous nature of regulatory work, be prepared to discuss how you ensure accuracy in documentation and compliance timelines. Share specific instances where your attention to detail made a significant difference in a project or submission.