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Labelling Operations and Compliance Manager

Managerial Job – Global Regulatory Affairs – Competitive – London, South-East England


Your new company
The organisation are looking to hire you as a Regulatory Labelling Manager to join the Regulatory team in their International HQ in London, conducting scientific innovation to create transformative medicines for people with serious and life-threatening diseases. As industry leaders, your new company has numerous ongoing research programs focused on the underlying mechanisms of other serious diseases.

Your new role
As Regulatory Labelling Manager you will be responsible for the oversight of the global regulatory labelling operations, processes, compliance and subsequent associated communications for core (CCDS) and regional product labelling. You will be working in a team environment where you will be the subject matter expert on labelling process operations excellence and compliance. As Regulatory Labelling Manager, you will be accountable for implementing process improvements, and the management and development of SOP and WI to support inspection readiness. Responsible for liaising with the global labelling strategy team (GLL and RLLs for EU and US) you will be accountable for management of the EU linguistic process, readability requirements, packaging and labelling review, along with supporting the review of communications and promotional materials for compliance with approved labelling.

Using your cross functionality to Interact with members of commercial, supply chain, affiliates and distributors, legal, safety, medical, and others will be an essential part of your role.

As Regulatory Labelling Manager, you will be accountable for oversight of the compliance for global labelling processes and supporting associated regional labelling for inspection readiness, including tracking of labelling updates and deviations, maintenance of controlled records for historical, current and ending labelling changes. Reviewing communications and promotional materials for compliance with approved labelling in Europe, as well as the management of the EU linguistic process, EU readability requirements, packaging and labelling. You will be supporting the development of US, EU, Canada and other regional product labelling, company core data sheets, and for the tracking and archiving of these documents and will also be responsible for proofreading and departmental QC work as needed, whilst reporting to the Head of Global Labelling, GRA.

What you'll need to succeed
You will hold at least a Bachelor’s degree, preferably in a life sciences field, alongside relevant experience in Regulatory Affairs in the area of labelling development, promotional product communications, and reviewing prescription pharmaceuticals or a similarly regulated industry. Your excellent planning, organizational, analytical, problem-solving, proofreading, and decision-making skills go hand in hand with your ability to lead and motivate others, driving projects to completion.

As Regulatory Labelling Manager, you will possess a working knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of product labelling and packaging. Your ability to exercise sound judgement and operate with a high degree of independence regarding routine and non-routine assignments is essential along with possessing excellent written and verbal communication skills.

Strong computer skills, including a working familiarity with electronic document management systems for compliant maintenance and version control of submitted, approved and in-use labelling.

Proficiency in a second language would be a bonus, but is not essential.

What you'll get in return
You will be offered a highly competitive salary, as well as an excellent range of benefits.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Summary

Job Type:
Permanent
Industry
Pharmaceuticals
Location
London
Specialism
Life Sciences
Pay
Competitive
Ref:
3207233
Apply Now

Talk to a Consultant

Talk to Jamie Webb, the specialist consultant managing this position, located in London City

107 Cheapside, London, EC2V 6DN

Telephone: 02034650081
For 50 years we've used our expertise to help people transform their careers.

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