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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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