Regulatory Affairs Pharmacist - Cape Town Verfied

Salary Negotiable Cape Town, Western Cape Cape Town, Western Cape more than 14 days ago 01-05-2021 12:00:02 AM
04-05-2021 8:17:21 AM
A global biopharmaceutical production company is seeking an SAPC Registered Regulatory Affairs Pharmacist.

Requirements:
B.Pharm or B.Sc. essential
2 – 5 Years Regulatory experience in the pharmaceutical manufacturing industry
Knowledge of MCC guidelines and policies
Must be independent
Strong interpersonal skills
Strong analysis and reporting abilities

Responsibilities:
Manage the life-cycle of the company product brand registrations in accordance with MCC requirements and company SOP’s
Maintaining regulatory compliance for all product brands, line extensions, material source changes etc,
Ensuring correctness of amendments printed packaging components
Providing regulatory advice on all brands
Supporting the QA, NPT, Procurement and Production departments
Communicating with all levels within the company
Keeping abreast of developments and changes within local regulatory environment
Managing product information databases
Checking and authorising the Bill of Materials, Terms of Supply, Registered Technical Details etc.
Evaluating and determining the relevance of and processing technical changes with the MCC
Present product brand support documents in a manner to ensure MCC approvals
Managing all regulatory aspects of product brands
Reporting on all authorisation data

Recruiter: Hire Resolve