Associate Regulatory affairs
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Job Location:
Monthly Salary:
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
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.
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.
