Regulatory Affairs Executive - Manchester, United Kingdom - Chiesi Farmaceutici

Chiesi Farmaceutici

Verified Company

Manchester, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Date: 9 Jun 2023

Department:
Technical Affairs

Team:
R&D, Pharmacovigilance & Regulatory Affairs

Job Type:
Direct Employee

Contract Type:
Permanent

Location:

Manchester, GB

We have an exciting opportunity for a Regulatory Affairs Executive to join our Technical team based in our Head Office in Manchester.

At Chiesi it is our people who are at the heart of what we do and achieve. A proud family business we are a Top Employer and a Great Place to Work in the UK.

We offer a blended approach to work, giving you the flexibility to work from home 2 days per week on mutually agreed days.

We also offer a great benefits package including Pension, Private Medical and Dental cover, 25 days leave, competitive salary, and an annual bonus scheme.

The role will be based at our Head Office, we are close to Manchester Airport with excellent public transport links and the added advantage of free car parking and electric charge points if you choose to drive to work.

We look forward to welcoming you to our team.

Purpose

To maintain product licences held by the Company.
To provide support and deputise for the Senior Regulatory Executive as and when required.

Profile

The role requires:

Life Sciences degree
Experience of working in a pharmaceutical regulatory/licensing environment.
Working knowledge of Regulatory Affairs legislative procedures and processes
Good communication and interpersonal skills
Ability to work well in a team environment
Good planning and organisation skills
High-level attention to detail and accuracy
Strong IT skills, including MS Excel, Word and Powerpoint
High standard of literacy and written communication.
Main Responsibilities

Preparation and publishing of regulatory submissions within eCTD format and update of the Regulatory Information Management System (RIMS).
Prepare responses to questions issued by the Regulatory Authorities.
Follow up with Regulatory Authorities on submissions and regulatory issues.
Request, review and submit all PSURs as required.
Writing, reviewing and advising on SmPCs and packaging.

Keep up to date with the latest guidelines and legislation (including monitoring regulatory websites), advising colleagues on implications of any changes.

File maintenance and organisation.
Maintain smooth running of the regulatory department and the licensing update processes.

Where appropriate, draft SOPs/Working Instructions for review by the Head of Regulatory & Pharmacovigilance prior to final approval and issue.

To create, amend and review Food Supplement packaging artwork in line with food supplement regulations and guidelines. To submit Food Supplement artworks to external regulatory and copy clearance agencies for review.
To perform other duties as required.
In line with annual objectives, contribute and support the UK Affiliate in its pursuit to become more sustainable.

DISCOVER ALL OUR JOB OPPORTUNITIES
Screen readers cannot read the following searchable map.
Follow this link to reach our Job Search page to search for available jobs in a more accessible format.