Director UK Regulatory

Job description:

Role Details

Director- Regulatory Affairs  

Role: Full-time, permanent

Location: Stockley Park, West London

Salary: Competitive + Bonus+ Pension + benefits

The Role

We’re seeking a meticulous and proactive Director of Regulatory Affairs Officer to join our West London team.

You will:

• Have oversight of local Regulatory Affairs operations, including but not limited to Preapproval & post approval submissions, database maintenance and ensuring overall compliance.
• Collaborate with Cross functional teams: Providing regulatory guidance and support to internal teams, including R&D, QA, QC etc for quality and supply chain improvements.
• Ensure that quality standards are met, and all regulatory submissions meet agreed deadlines.
• Manage, evaluate, and maintain all regulatory documentation, ensuring accuracy and completeness for internal and external purposes.
• Maintain Operational Oversight and assign/monitor day to day activities of the UK regulatory team.
• Ensure implementation of Quality Management System (QMS) within Affiliate organisations aligned to Corporate Policies and Procedures and to ensure fulfilment of local Regulatory Affairs obligations
• Responsible for management and implementation of IT systems for Regulatory Affairs operations, including Regulatory Information Management System (RIMS)
• Oversight of local Regulatory Affairs operations, including but not limited to submission, database maintenance of variations, renewals, and ensuring overall compliance
• Vendor selection, qualification and management of local vendors in collaboration with Regional Regulatory Compliance & Quality Team
• Support Affiliates in audit and inspection readiness in collaboration with Regional Teams
• Reporting KPI and metrics to Accord ELT to demonstrate performance and compliance of Regulatory Affairs department.
• Continuously track changes in regulatory legislation, guidelines, and standards to ensure the company remains compliant. 

The Person

 

• Life-science graduate with demonstrable experience in broad regulatory affairs and pharmacovigilance.
• Experience in global pharmaceutical companies, with special reference to oversight of regulatory affairs, PV systems, quality, and compliance.
• Experience in working with and monitoring of CROs or vendors.
• In-depth knowledge of pharmacovigilance processes and EU regulations, being able to ensure consistency and efficiency as well as monitor and maintain priorities and project progress across regions.
• Must have proven managerial experience (i.e., decision making and problem solving, people management)
• Must have excellent communication, interpersonal and leadership skills
• Must be a good motivator and be able to coach and mentor personnel
• Strong attention to detail and persistence in following tasks through to completion
• Good organizational and prioritization skills
• Good interpersonal skills

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 19/09/25. 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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