Regulatory Affairs Pharmacist
Cape Town, WC, ZA, South Africa
Job Description
Regulatory Affairs Pharmacist
Active registration with SAPC is mandatory.
SAHPRA experience:
Must have personal, hands-on experience in/be knowledgeable on:- conducting due diligence (gap analysis) and advising on the feasibility of registration potential of a new product dossier.
- preparing and submitting eCTD dossier sequences (including preparing country specific documents) as applicable to new applications for registration, quality and clinical variations, baselines, responses to queries, including associated tasks, for example e-CTD validation (and fixing validation errors), liaising manufacturers, laboratories to obtain necessary information etc.
- the requirements to register and manage the lifecycle of generic medicines and extension applications. Experience with biological medicines will be an advantageous (new registrations and variations). Knowledge on previously accepted dossier formats (like paper CTD, e-submission, MRF) will be advantageous.
- Experience with other regulatory authorities such as NMRC, ZAZIBONA, BoMRA etc. would be advantageous.
Must be able to work in a team towards a common goal (i.e. RA department and company as a whole), but otherwise capable to run with a project in own personal capacity.
Willing to act as a deputy RP will be an advantage.
Must be based in Cape Town and have a reliable car to travel to/from work and be punctual (office based in Century City).
Job Types: Full-time, Permanent
Work Location: In person
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Job Detail
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Job IdJD1550700
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCape Town, WC, ZA, South Africa
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EducationNot mentioned