Company: Strides Pharma Science Ltd
Position Title: Executive - Regulatory Affairs
Work Place: Bangalore
Job Purpose: Responsible for compilation & Submission of dossiers & lifecycle management.
Reporting to: DGM
work experience: 2years-5years
Qualification: BPharma/MPharma
Key Job Responsibilities :
- Compilation of Dossiers (CTD, ACTD, Regional) as per country-specific MOH guidelines.
- Preparation and Review of BFIF as per EU guidelines.
- Compilation of Deficiencies response to the Agency.
- Compilation and evaluation of Elemental Impurities ICH Q3D
- Review of the Dossiers as per the current prescribed guidelines of the respective regulatory authorities.
- Handling and responding to all the product-specific queries arising from various countries
- Preparation of Technical Packages & checklist for the county
- Preparation of SPC, Tender Documents & WHO GMP Stability
- Review of QA documents, documents required for regulatory agencies and Package insert & labeling information
- Coordination with R&D, QA/QC and License department
No comments:
Post a Comment