Regulatory Affairs Manager CMC contract job

2 weeks ago


Uxbridge, United Kingdom Hays Specialist Recruitment Limited Remote Work Freelance Full time

Regulatory Affairs CMC Manager - International marketsYour new companyThis well-known biotech is looking for an experienced Regulatory Affairs CMC Manager to join their well-established team on a contract basis. This role will mostly be managed from home with one quarter travel to the office based. This is a 12-month contract job with scope for extension.Your new roleIn this contract job as Regulatory Affairs CMC Manager you will be responsible for the generation of country-specific (international) regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.The Regulatory Affairs CMC Manager is responsible for ensuring CMC regional (international) issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies, as well as reviewing the preparation of M2 and 3 CMC components of filings and assessing fitness of purpose for submission in the relevant countriesWhat you'll need to succeedIn order to be considered for this contract job as Regulatory Affairs CMC Manager, you must have previous CMC experience, ideally working in International markets. Those with large molecule / biologics experience would be at an advantage.What you'll get in returnFlexible working, good hourly rateWhat you need to do nowFor more information on this or any other Regulatory Affairs contract jobs please apply to this advert and ask for Victoria Dunlop 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 about your career.



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