Manager - Regulatory Affairs; Region

Position: Manager - Regulatory Affairs (Africa Region I)
Location: Dholka

Job Title:

Regulatory Affairs - Africa Region I

Position:
Manager Regulatory Affairs

Location:

Dholka, Near Ahmedabad, Gujarat

Job Type: Full-Time

Qualification :

B. Pharma/M. Pharma

Experience : 10-15 Years

Job Responsibilities:

· To ensure Registration dossier submission of products in different Africa countries (Region I) as per agreed timeline.

· To ensure Renewal of registered product prior to validity expiration of Africa countries (Region I).

· To Review Registration and Re-registration dossiers before submission in all Africa countries (Region I)

· To maintain country-wise registered product status for all Africa countries (Region I)

· To co-ordinate with other departments R&D, QA and QC for ensuring the filings & query responses.

· To provide technical support to team for preparation of Registration/Re-registration dossiers and query responses.

· To prepare documents for variation filings as and when required for all Africa countries (Region I)

· To update registration information in SAP & Cadinet for Africa countries (Region I)

· To clear issues of commercial Order related to regulatory department for Africa countries (Region I)

· To review the tender requirements and extend necessary support by providing the required documents and samples.

· To co-ordinate with International country managers for smooth scheduling the registration activity.