Regulatory Affairs Officer

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 (SV) 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.

Other duties include:

• Oversee submission planning and review the submission documentation for CAPs
• 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 CAPs
• Maintain compliance with EU guidelines and regulatory requirements as well as with internal SOPs
• Collaborates with AW team for implementation of SVs for CAPsMeet 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 UK/EU pharmaceutical regulatory legislation
• 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 01/09/25. For more information, you can contact us on: [email protected]

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.

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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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