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  and follow our latest news on Linked In 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 products, 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.

• 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.

• 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.

• Experience supporting MHRA submissions.
• Expe…