Regulatory Submissions Writer

2 weeks ago

London, United Kingdom X4 Group Full time

**The Company:**

Independent and friendly medical communications agency, which prides itself in having a flat structure. A well-established, successful MedComms team that is now expanding into the regulatory space. A key focus is placed on work-life balance, ensuring thattheir people keep to core hours and that they’re only ever working at 80% tops.

**Regulatory Submissions Writer Role:**
- Lead the process of preparing regulatory submission documents: NDAs, BLAs, Briefing Documents etc.
- Contribute to other regulatory documents: CTD modules, integrated summary of safety (ISS), integrated summary of efficacy (ISE) etc.
- Heavily involved in liaising with clients.

**Regulatory Submissions Writer Requirements**:

- 4/5+ years of Regulatory Medical Writing experience working with FDA and EMA guidelines.
- Exceptional written and verbal communication skills.
- Solid understanding of the drug development process.

**100% remote**

If this role isn't what you're looking for don't worry. At X4 Communications we cover all permanent and contract positions, with specialist industry sector teams. You can check out all of our roles on our website and sign up for job alerts so you're thefirst to know about a new opportunity.

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