Job Description
Hire Resolve's client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance requirements.
Responsibilities
- Lead, manage, and execute strategic direction as the regulatory affairs manager.
- Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
- Provide input to the regulatory strategy in line with business objectives.
- Manage and implement safety updates where required.
- Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
- Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
- Write and develop S...
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