Experience

ProductLife Group

• France
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Regulatory Affairs Officer.

  • Oct 2020 - Present

  1. In charge of pre & post approval projects for Europe and ROW countries. 2. Preparation of regulatory strategy for pre-submission activities. 3. Handling of Module-1 related activities in DCP/MRP/NP for initial submission & eCTD publishing. 3. National phase texts and labeling preparation. 4. Handling of post approval activities like, variations, MAT, CPP, Sunset Clause for different member states. 5. Performing all type of publishing activities for EU by using Knowledge net eCTD software. 6. Provide regulatory support to RO, RA and CMC team, whenever it is required. 7. Proper archival of documents to country specific folders. 8. Effective communication with stakeholders & country specific agencies. Show less