Senior Manager/Manager - Regulatory Affairs - Emerging Markets

1.Leadership qualities- Within team as well as for Business communications
Good regulatory writing skills based on guidelines

2.Manage Team of 5+ Team members for : Dossier preparations/deficiency responses and launch related activities for catering to Emerging markets RCIS, Latam, Asia, ME and Africa.

3. Dosage forms covered - Respiratory preparations/ OSD/ Injectable. Strong & in-depth Knowledge of Respiratory preparations/ OSD/ Injectable guidelines of USFDA/EMEA/ICH/ASEAN/SAPHRA/EAEU etc along with review of Technical data required for new registration & deficiency response

(i) API data: Thorough DMF review & complete understanding of ICH guidelines/ANVISA understand intricacies of impurity profiling and impact, API-specifications and methods/detailed understanding of AMV requirements and parameters included/stability/Photo stability and Forced degradation, etc.

(ii) FP data: Thorough review of FP data such as PDR and required Characterization studies /Process Validation/ understand intricacies of impurity profiling of FP w.r.t. API & their impact, FP-specifications and methods/detailed understanding of AMV requirements and parameters included/ stability/Photo stability and Forced degradation, etc. in line to ICH

4. Knowledge of Country specific requirements for Emerging Markets - regions: Asia/ Africa / Middle East/ Latam and Russia-CIS.

5. Hands on Experience with Dossier compilation and review as per eCTD/CTD/ACTD/Country Specific formats for product Registration

6. BE/Clinical requirements Well versed with BE/ Clinical requirements for different types of filings NCE/Generic for all dosage forms for Respiratory products and other NCEs and Generics.

Concept and application of In-vitro data/CDP/IVRT
7. Correct interpretation, communication & closure of deficiencies, from country counterparts, consultant and MoH on priority & maintain overall query status

8. Strong Communication for

(i) Correct interpretation of guidelines & requisition of data such as Administrative data / Technical data for API & FP/Artworks/Samples/WS/Raw materials/Clinical/Non-Clinical / Pharmacovigilance from various from cross-functional departments viz., Sourcing/R&D/Plant-QA/QC/Medical/PV / Packaging required for registration & deficiency replies.

(ii) Communicate with regional counterparts for registration/queries requirement.

9. Maintain dossier submission, filing, approval & deficiency, new launch status