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

G&L Healthcare

Verified Company

London, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

We are an industry-leading 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 grow we are looking for a CMC consultant to join our team of Regulatory Affairs professionals on a permanent basis in our Paddington office.

Our permanent roles are hybrid so all G&L's employees would be required to work from the office a minimum of twice a week.

The Role

Typical duties will 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 & EUfocused, including working on evolving and emerging trends and new policies.
Guiding our clients and team members through complex regulatory affairs projects.
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.

Required Skills:

36 years of experience in CMC authoring and 310 years of relevant industry experience
CMC authoring experience essential (previous coordination role is not sufficient), including authoring module 3 and CMC variations.
Experience responding to manufacturing site change controls and providing CMC regulatory advice and strategies.
Must have experience in CMC postapproval procedures.
Previous experience working for a consultancy company would be a benefit.
Experience across multiple therapy areas would be beneficial.
Experience with Mature Product/Small Molecules preferred.
Impeccable communication skills.
A flexible approach with diplomacy and negotiating skills.

Your daily workload will be fluid and completely responsive to our clients' requests - and no project is the same.

We need someone who is an excellent communicator, a selfless team player, a brilliant multitasker - but most of all, someone who has a good sense of humour We want to enjoy our work, have a happy office and consistently deliver exceptional services to our customers - so we are only recruiting people with a can-do, why-not, positive attitude.

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._

Job Types:
Full-time, Permanent

Benefits: