Job Title:  Regulatory Officer

Role Details

Regulatory Officer EMENA

Role: Permanent Full Time

Location: West of London (Site Based)

Salary: Competitive plus bonus plus pension

The Role

We’re seeking a driven Regulatory Officer to join our growing team at our new Head Office in West London. You will be suitably qualified with previous exposure to Regulatory affairs CMC experience and looking to take the next step in your career.

In this fast-paced role, you’ll be involved in post-approval lifecycle management (variation compilation/submissions/registration, tracking & maintenance) for the portfolio of products registered in the UK & Europe, in accordance with regulatory requirements and Company procedures and strategy.

Responsibilities include:

• Compile, submit and maintain Marketing Authorisations (e.g. CMC variations, PIQ, 61(3), BSV’s substantial amendments)
• Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
• Obtain MAA variation approval/notifications
• Obtain tracking certificates of pharmaceutical products from UK/NL/IE for MENA/CIS and other ROW countries
• Meet all compliance timelines when performing regulatory activities 
• Maintain regulatory documentation, spreadsheets and databases
• Maintain EMENA regulatory standard operating procedures (SOPs)
• Carry out regulatory training activities within and outside the Department
• Monitor regulatory inboxes
• Perform general regulatory duties as required

The Person

• Previous exposure and experience in a similar regulatory role or a background in healthcare or science with the ability to understand technical/medical terms.
• Good understanding of relevant UK/EU pharmaceutical regulatory legislation, be familiar with MHRA/MEB and registration procedures
• Degree-level qualification in a life science subject.
• Strong project management skills, able to multi-task, manage your own workload and assess priorities to meet deadlines.
• Good IT skills, including using company systems and MS Office.
• Works in a calm and methodical manner, follows instructions closely and takes a practical and proactive approach to solving problems.
• Meticulous eye for detail, with excellent proofreading skills.
• Excellent communication and interpersonal skills (in written and spoken English), with the ability to relate to people of all levels and navigate cultural differences with ease.
• Driven to get things right first time, arrives with solutions and knows when to ask questions.

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 31/07/25. For more information, you can contact us on: careers@accord-healthcare.com

A Bit 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.

Footer

All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Requisition ID: [[id]]