Regulatory submissions to health authorities worldwide;
 Support submission planning including applying intelligence and develop regulatory
strategy
 Support preparation and maintenance of regulatory files
 Support submission of regulatory files, response to questions from health authorities and
maintenance of marketing authorisations globally, e.g.:
 MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, post
approval changes and commitments
 Support interactions with affiliates
 Regulatory interactions with health authorities
 Support the planning and conduct of regulatory authority interactions. Provide input to the
preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal
meetings
 Provide input to affiliates for preparation of health authority interaction
 Monitor and renewals handling.

experience

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