Regulatory Affairs Associate

Regulatory Affairs Associate

Manchester

Pharmaceuticals

12 month Contract - £800 per day Outside of IR35

Regulatory Affairs Associate needed for a leading Engineering organisation based in Manchester who are looking to employ an experienced Regulatory Affairs Associate on a contract basis

What the role entails:

Some of the main duties of the Regulatory Affairs Associate will include:

The Regulatory Affairs Associate (RAA) assists the Regulatory Affairs Management (RAM) team in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and company standards for designated therapy areas and products.

Major Responsibilities:

• Input regulatory knowledge, intelligence & information into relevant systems and databases maintaining data accuracy and up to date information for the group and relevant databases and platforms.
• Maintain documentation & records management in EDMS (ie, Veeva Vault or ANGEL) in accordance with defined standards & process and as requested by RAMs & Global Regulatory Execution teams (GRETs) eg. support with Submisison Ready standards/Housestyle skills & QA checks, specific authoring tasks, liaison with Regulatory Operations
• Support the product registration and maintenance of designated product applications in accordance with company standards of regulatory compliance

• Provide support across the group for assigned non-drug project roles & responsibilities, eg. as a designated point of contact for external partner, provide specific technical expertise.
• Be the interface with HA/HA systems for designated regulatory tasks, eg. co-ordination & logistics for HA meetings, management of HA fees, receipt of incoming HA correspondence
• Responsible for ordering & tracking of specific regulatory requirements eg. i) registration samples, ii) Certificates of Pharmaceutical Product & associated legalization where appropriate iii) any other legal documentation eg. Letters of Authorization, Powers of Attorney, Translations as required.

What you need to be the successful Regulatory Affairs Associate:

In order to be the successful Regulatory Affairs Associate and have a chance to gain such an exciting opportunity you will ideally need to have the following:

• An understanding of all Software Configuration Management Policies, principles and processes
• A professional Configuration based qualification such as CMII certification, would be desirable
• Minimum of 5 years' experience in a Software Engineering function
• Hold an ITIL Foundation Certificate or higher
• An extensive working knowledge MS Office application
• Be able to work to tight schedules and budgets
• Demonstrated attention to Detail and Data Integrity.
• CM2 Accreditation/ ITIL

This really is a fantastic opportunity for a Regulatory Affairs Associate to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

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