Regulatory Operations Manager

2 weeks ago


South East England, United Kingdom Page Group Full time

Exciting opportunity to join a fast growing biotech in a pivotal point of growth.

**Client Details**

I have partnered with a fast growing biotech businesses based in the south who are growing significantly. Due to growth they are looking for a Regulatory Operations Manager - PART TIME to join the team.

**Description**

Reporting to the Regulatory Affairs Manager, the Regulatory Operations Manager is a part-time contract offering 2-4 days per week. The successful applicant will be responsible for publishing and compiling electronic submissions as required for CTAs, INDs,Scientific Advice Applications and pre-INDs; Setting up EU and US regulatory submission portals; submitting and managing electronic submissions; providing guidance to multidisciplinary teams on submission structure strategies in accordance with applicableRegulatory Agency regulations, guidelines, and specifications; assisting with the developing and maintaining of regulatory submission publishing standards and procedures; and providing ongoing regulatory support to Project Teams.

This role is available on either a staff or contractor basis.

**Profile**

**Job Offer**

Excellent Benefits and development opportunities



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