Cmc Regulatory Affairs Consultant - Remote, United Kingdom - G&L Healthcare

G&L Healthcare

Verified Company

Remote, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

G&L Healthcare Advisors is a fast-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.

As demand for our services and solutions continues to increase, we are looking for a CMC contractor to join our team of Regulatory Affairs professionals on a contract basis.

The contract will be between September December 2024.

The Role
As part of G&L's team of CMC professionals, the typical duties would include:

Lifecycle management for pharmaceutical, biologics or vaccine products.
Creation of efficient and robust strategic CMC lifecycle submission plans and overseeing the successful completion of the committed plan.
Working in global regulatory affairs, particularly UK & EU, including working on evolving and emerging trends and new policies.
Potentially supervising and training junior staff within G&L's organisation.
Preparing a variety of CMC regulatory documents.
Working with manufacturing sites on change control projects; providing regulatory advice and strategic guidance.
Managing multiple projects simultaneously; providing data assessment and conclusions.
Identifying risks associated with submission data and information packages and then proposing mitigation plans.
Efficiently interacting with G&L's clients and internal stakeholders as required.
Identifying improvement opportunities for CMC Regulatory processes, policies, and systems.
Contributing to process improvement and regulatory intelligence projects.
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race._
We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process._
G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity._