Officer - Regulatory Affairs - Mumbai ( Fort )

Designation - Officer - Regulatory affairs

Job Location - Mumbai

Department - Regulatory affairs

Role & responsibilities

1. Dossier Preparation ACTD/CTD/ ECTD Country Specific for ROW market & to ensure error free & timely submissions as per marketing dept. timeline.

2. To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.

3. To review technical documents like process validation, AMV, Stability and CDP etc. received from Site QA or R&D/ADL against DMF/Dossier requirements.

4. To Co-ordinate with respective dept. in HO /Plant /ADL/R&D for documents & samples required for dossier / registration purpose.

5. Artwork Checking & development for registration and commercial purpose as per regulatory requirement.

6. To Maintain & Update all documentation & dossier record; to update registration status

Preferred candidate profile

Education - M. Pharma, B. Pharma

Experience - 1 Year +

Must Have experience of Dossier preparation, Worked for ROW Market, Artwork preparation & Checking.

Good Communication, Drafting & Documentation knowledge.

Teamworking