Regulatory submissions to health authorities worldwide;<br /> Support submission planning including applying intelligence and develop regulatory<br />strategy<br /> Support preparation and maintenance of regulatory files<br /> Support submission of regulatory files, response to questions from health authorities and<br />maintenance of marketing authorisations globally, e.g.:<br /> MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, post<br />approval changes and commitments<br /> Support interactions with affiliates<br /> Regulatory interactions with health authorities<br /> Support the planning and conduct of regulatory authority interactions. Provide input to the<br />preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal<br />meetings<br /> Provide input to affiliates for preparation of health authority interaction<br /> Monitor and renewals handling.<h3>experience</h3>7