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Designation: Regulatory Affairs Pharmacist
Location: Vikhroli, Mumbai, Maharashtra
Job Description:
Company Compliance:
- Responsible to handle activities of South Africa and possibly other export countries.
- Approval of masterbatch documentation prior to product production.
- Responsible for SOP implementation/review, update, and compliance.
Product Registration:
- Liaise with Regulatory Manager for regulatory requirements prior to dossier acquisition.
- Responsible for anticipating, receiving, and submission of new product registrations for a particular financial year.
- Responsible for the submission of generic dossiers, NCE’s, and possibly biological and complementary medicines.
- Ensure on-going regulatory compliance of the existing product portfolio.
- Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of company products.
- Ensuring that the company is aware of significant local and international regulatory issues that can impact the business.
Documentation management:
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality-related records are available and retained.
SAHPRA Submissions:
- Responsible for new product applications.
- Compilation and submission of Post -Registration amendments to ensure dossier compliance.
- Responsible for pre and post-registration SAHPRA Committee recommendation responses to ensure product registration.
- Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation.
Pharmacovigilance:
- Responsible for Pharmacovigilance monitoring within the group.
Other
- Providing status reports to the regulatory department head on the status of projects currently worked on.
- System implementation.
Qualification: B.Pharma
Experience: 2-7 Years
Salary: Negotiable
Contact Details:
YUshanta
ymoonsamy@austell.co.za
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