Senior Regulatory Affairs Executive

3 weeks ago

Maidenhead, United Kingdom Hays Specialist Recruitment Limited Full time

Senior Regulatory Affairs Executive, Office Based, Permanent, Pharmaceutical, Generics, Reg Affairs
**Your new company**
Looking to progress your career in the Regulatory Affairs field in 2023? An emerging, generics pharmaceutical company is looking for a Senior Regulatory Affairs executive to join their brand new & rapidly expanding team Your new company has patient safetyat the heart of what they do; from manufacturing to packaging of products. Their goal is to become a global pharmaceutical giant - a goal for which they are very much on track
In joining their team as a Senior Regulatory Affairs Executive, you have a once in a life-time opportunity to progress your career, harness an unrivalled understanding of drug development and Regulatory Affairs, as well as having your own autonomy and freedomto grow.
**Your new role**
In your new role as Senior Regulatory Affairs Executive, your focus will be on post-approval activities within a growing Regulatory team, with the opportunity to mentor and guide a team. Your main responsibilities here include:

- Interfacing with Regulatory Authorities to facilitate submissions
- Acting as a point of contact for third-parties, and internal/external teams.
- Keep up-to-date with regulatory changes, ensuring constant compliance with this and companies' SOPs.
- Assist RA Manager in coaching and mentoring junior members of the team.

This is a fantastic opportunity to gain exposure to a new range of products, in an innovate team and company.
**What you'll need to succeed
**In order to be a successful applicant for the position of Senior Regulatory Affairs Executive, you will need:

- A Pharmacy / Chemistry degree or similar
- Significant experience in Regulatory Affairs (approx. 4 years), with a focus on Post-Approval
- Experience in submitting complex Type 1A, 1B, II variations
- Good understanding of the current UK and European regulations
- Exposure to NeeS/eCTD format
- Generics experience

**What you'll get in return**
Flexible working hours, generous holiday, staff gym.
**What you need to do now**
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

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