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Regulatory Affairs Manager
£competitive plus benefits

Due to expansion in the company, a fantastic opportunity has arisen with a leading pharmaceutical company based in Hertfordshire for a Regulatory Affairs Manager. This is a permanent position offering a competitive salary and benefits package as well as great scope for career progression. You will be working within the EU team across the entire lifecycle of products (from development to marketed products) in all therapy areas except Oncology and Neuroscience.

Role responsibilities:

•Supports regulatory strategy and manages timelines and resources to meet project needs
•Takes responsibility for the quality and completeness of regulatory submissions for Clinical Trial Applications, amendments updates etc. for NCEs and MAAs
•Is accountable for overall quality and compliance of regulatory submission documents to the appropriate regulatory bodies and acts as the day to day contact point with regulatory authorities for communications relating to proposed/pending clinical trial applications
•Provides input into clinical and drug development plans for projects allocated
•Provides regulatory input and project management for all variations and other submissions for projects allocated
•Provides assistance in making submissions in emerging markets for assigned products.
•Works closely with colleagues to ensure that the EU regulatory strategy is addressed and any required submissions are made within the specified timeframes
•Organises Regulatory Agency meetings and accompanying briefing documents in accordance with project requirements
•Works closely with colleagues at ESL and other offices as well as CROs and Partner companies to ensure that correct and complete submissions are made within agreed timeframes
•Provides EU regulatory input into IPTs for the projects allocated
•Influences regulatory related work processes that span across multiple teams, functions or departments

Candidate requirements:
•Educated to degree-level in a scientific discipline
•Previous line management experience is desirable but not essential
•Experience of working with Marketed Products is desirable
•Previous experience (4 years+) in Regulatory Affairs in the UK
•Good EU experience as well as MAA and CTA experience (compilation and submission)
•Self-motivated and enthusiastic in character

You must be eligible to live and work in the UK

If this role sound of interest, please contact Ridda at Regulatory Professionals on 0118 952 2797 or email your CV to

Key words: regulatory affairs manager Regulatory Affairs Project Manager regulatory affairs senior officer CTAs MAAs Marketing Authorisation Applications Clinical Trial Applications EU Europe UK Hertfordshire Buckinghamshire London Middlesex Essex Berkshire permanent office-based relocatable

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