Regulatory Affairs Officer, Labelling - Watford, United Kingdom - Cpl Life Sciences

Cpl Life Sciences

Verified Company

Watford, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Reference Number:

JO
Regulatory Affairs Officer, Labelling

Rate:
Negotiable

Job Type:
Permanent

Location:
Watford

Regulatory Affairs Officer, Labelling

Watford UK - Remote

Up to £34,000

An exciting opportunity to join a rare disease biotech business that works across a range of therapeutic areas. The business has a range of plasma-derived biological products that are registered in global markets.

The business is looking for a Regulatory Affairs Officer to join their labelling team and support with all labelling activities.

This position will work closely with the current Regulatory Affairs Labelling Manager and will carry out the following activities:

Prepares, in collaboration with the relevant Company departments, the labelling material to be included in the registrations, renewals and variations, ensuring the compliance with the relevant regulations.
Coordinates the collection of information, from RA colleagues and from the relevant Company departments, for the preparation of the labelling text in line with the defined timelines.
Collaborates in the preparation of the labelling mock ups, ensuring the compliance with the authorized text.
Evaluates the impact of change controls on the labelling materials.
Provides regular updates on regulations, guidelines, etc. related to the area of competence.
Contributes to the preparation of the answers to the list of questions and commitments received from the Authorities.

Requirements:

Scientific degree

One year of experience in Regulatory Affairs Labelling with hands-on management of labelling documentation and artwork mock-ups.

Knowledge and understanding of applicable pharmaceutical regulations with industry regulatory experience.

Problem-solving and analytical mindset.

Excellent communication, organizational, and interpersonal skills.