Senior Regulatory Officer - Hertfordshire, United Kingdom - Proclinical

Proclinical

Verified Company

Hertfordshire, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Proclinical are recruiting a Senior Regulatory Officer for a consultancy. This role is on a permanent basis and is located in Hertfordshire. The client is focused on distributing international patient recruitment methods for clinical trials.

Responsibilities:

Handle the sunset clause status for all UK marketing authorisations aligned with local poly and EU guidelines.
Arrange confirmation of submission strategy.
You will guarantee SPPs for UK national licences are upheld and aligned with business procedures and regulations.
Consistently update the eMC database with any changes to approved SmPCs and PILs.
To assist with marketing team actions, you will produce abbreviated prescribing information when requested.
Support the execution of UK risk management plan actions.
Uphold consciousness of present UK regulations and any other regulatory needs and concerns.
Offer assistance for general team actions.
Other duties may be assigned to this role.

Key Skills and Requirements:

Educated to a degree level in a life science field or similar.
Acquaintance within regulatory affairs.
Communication skills both verbally and in writing.
Familiarity in handling large volume and fastpaced product portfolios.
Takes a flexible approach to facilitate prioritisation aligned with the company's needs.
Able to efficiently contribute to working groups or crossfunctional project teams, as well as successfully cooperate with coworkers.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-AY1

Regulatory