356,357 Regulatory Affairs Specialist (Submission)
004-placeholder India, Tunisia - Onsite, Remote work possible - Life Cycle - Regulatory Affairs & Operations - 003-clock Permanent contract
Specific activities and responsibilities:
Regulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes) Creation/update Country Label Deviation Update and approval local artworks Provision of local reg intel Update local site licenses (GMP site renewals) Local Regulatory SOP review and update Health Authority Fee maintenance Coordinate of Response to Questions Preparation/update Product Information Preparation /update local abbreviated PI (if applicable) Preparation of Renewal Procedure eg local document identification and preparation Preparation for Variations inc. RtQs, requesting/securing centrally provided documentation Preparation for Annual Safety Updates/HA instructed safety updates Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of Mas
Providing support during external and unannounced audits.
Required education:
Degree in life sciences related field
Required experience :
4+ years RA experience
Required technical skills:
RA knowledge and background, MS-Excel basic and Presentation skills, coordination/organizational/multi task skills
Additional experience and/or skills:
Organized, methodical, adaptable, sense of priorities, rational, ready to learn and grow.
356,357 Regulatory Affairs Specialist (Submission)
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