Regulatory Affairs Officer

2 weeks ago

Slough, United Kingdom IPSEN Full time

**Title**:
Regulatory Affairs Officer

**Company**:
Ipsen Ltd

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.

We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.

The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.

We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

The **Regulatory Affairs Officer **is a key member of the **Regulatory **team and reporting to** **the Senior Regulatory Affairs Manager for UK and Ireland.

Your main areas of responsibility will include:
**Managing regulatory submissions**
- Manage safety updates to marketing authorisations, including management of risk management plan updates
- Ensure business stakeholders are informed of all relevant regulatory updates
- Participate in the review of product prescribing information in line with the ABPI Code for the UK and IPHA Code of Practice for Ireland

**Regulatory Intelligence**
- Maintain an up to date awareness of the regulatory environment in the UK and Ireland whilst communicating relevant aspects to UK and Ireland as well as Group colleague

**Maintaining compliance**
- Ensure all the Regulatory Affairs activities are conducted within the framework and full compliance

The role will initially be based in Slough but will transition to our new Global Hub in Paddington during Q1 2024.

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