Regulatory Affairs Associate

Permanent Regulatory Affairs Associate UK and EU Markets Labelling Submissions

Your new company
A global business conglomerate with diverse interests in pharmaceuticals, financial services, and real estate, with offices in 30 countries and its products sold in more than 100 markets. A global leader in integrated solutions and offer a unique platform of services across the drug life cycle – from drug discovery and development to commercial manufacturing of drug substances and drug products. Moreover, they have a pool of over 700 scientists committed to research & development programs. They are looking for a Regulatory Affairs Associate to join their UK team with Strong knowledge of EU regulations and requirements for labelling.

Your new role
There will be a predominant focus on the maintenance of documents, including initiation, review, or approval of document change requests for new documents and revisions. Moreover, provide artwork assistance for generation of annual reports and appropriate supplemental filings and variations to support drug product manufacturing transfers; and other variations such as batch release and labelling. You will be expected to assist team with labelling updates as required to ensure timelines remain on target. Furthermore, it is desired that you participate in Global Safety Labelling & CCDS cross functional meetings. You also need experience within the EU region.

What you'll need to succeed
Strong knowledge of EU regulations and requirements for labelling. Knowledge of PV safety and reporting requirements for EU region. Minimum of 3-5 years’ experience in a regulated industry with 1-3 years’ Regulatory Affairs experience.

What you'll get in return
You will get a market competitive salary with an annual bonus. You can work two days a week remotely. Pension Scheme, 25 days holiday and bank holidays There is the opportunity for regular promotion opportunities, with amazing career progression.

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.
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Job Type
Working Pattern
Flexible Working,Full-time
Regulatory Affairs

Talk to a consultant

Talk to George Costard, the specialist consultant managing this position, located in London-City
4th Floor, 107 Cheapside

Telephone: 44 333 010 3767

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