Regulatory Affairs Officer

Title:

Regulatory Affairs Officer

Company:

Ipsen Ltd

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Regulatory Affairs Officer

Location: Paddington, London (Hybrid Working)
Department: Medical & Regulatory Affairs, UK & Ireland

About Ipsen

At Ipsen, we are committed to improving the lives of patients through innovative medicines in areas of significant unmet need. Whilst this role will work across all Ipsen roducts, oncology is a key strategic focus, and this role offers the opportunity to support a portfolio of established and emerging oncology therapies that make a meaningful difference to patients across the UK and Ireland.

The Opportunity

We are seeking a Regulatory Affairs Officer to join our UK & Ireland Medical and Regulatory Affairs team. This role offers broad exposure across Regulatory Affairs, Quality and Compliance, supporting both marketed and pipeline products, with a strong focus on our oncology portfolio.

Reporting to the Senior Regulatory Affairs Manager, you will play an important role in ensuring regulatory compliance, supporting licence maintenance activities and helping to bring innovative medicines to healthcare professionals and patients, with an initial focus in our oncology portfolio.

Key Responsibilities

Regulatory Affairs

• Support the preparation and submission of regulatory lifecycle maintenance activities in the UK and Ireland.
• Coordinate and implement approved regulatory changes, including updates to SmPCs, PILs, labels and packaging materials.
• Support responses to requests from regulatory authorities, including the MHRA and HPRA.
• Maintain regulatory databases, submission trackers and document management systems.
• Work closely with Global Regulatory Affairs and cross-functional stakeholders to support regulatory strategy and execution.
• Contribute to licence maintenance and optimisation activities across Ipsen's oncology and specialty care portfolio.

Regulatory Intelligence

• Monitor and communicate developments within the UK and Irish regulatory environment.
• Conduct competitor intelligence activities and monitor regulatory developments within oncology.
• Support the assessment of regulatory changes that may impact the business and patients.

Compliance & Quality

• Ensure all activities are conducted in accordance with applicable regulatory requirements, GxP standards and company procedures.
• Support controlled document management and quality systems activities.
• Assist with change controls, deviations, CAPAs and inspection readiness initiatives.
• Support complaint administration and investigation activities as required.
• Contribute to compliance reporting and KPI generation.

Cross-Functional Collaboration

• Partner with colleagues across Medical Affairs, Pharmacovigilance, Quality, Supply Chain, Commercial and Global Regulatory Affairs teams.
• Support continuous improvement initiatives within the Regulatory Affairs and Quality function.
• Help maintain a culture of compliance, quality and patient focus.

About You

Essential Requirements

• Degree in Life Sciences or a related scientific discipline.
• Experience working within the pharmaceutical industry.
• Understanding of the UK medicines regulatory framework.
• Basic knowledge of GxP requirements.
• Strong organisational and project management skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and work to tight deadlines.
• Strong attention to detail and commitment to quality.

Desirable

• Experience supporting MHRA submissions.
• Experience with Regulatory Operations activities.
• Experience working with Quality Management Systems.
• Knowledge of quality processes, including deviations, CAPAs and change controls.
• TOPRA membership or working towards membership.
• Previous experience supporting oncology products.

What We're Looking For

The successful candidate will be a proactive, collaborative and detail-oriented regulatory professional who enjoys working in a fast-paced environment. You will be comfortable building relationships across functions, managing competing priorities and ensuring activities are delivered to a high standard.

Most importantly, you will be motivated by the opportunity to support innovative oncology medicines and contribute to improving outcomes for patients.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.