17 Oct
|
Acme Services
|
Mumbai
17 Oct
Acme Services
Mumbai
Job highlights
in HO /Plant /ADL / R&D; for documents & samples required for dossier / registration purpose
Artwork Checking & development for registration and commercial purpose as per regulatory requirement . To Maintain & Update all documentation & dossier record
Dossier Preparation ACTD/CTD/ ECTD Country Specific for international market ( Global-Market) & to ensure error free & timely submissions as per marketing Dept. timeline.
To evaluate & respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query.
To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D;/ADL against DMF/Dossier requirements
To Coordinate with respective dept.
in HO /Plant /ADL/R&D; for documents & samples required for dossier / registration purpose.
Coordination with all stakeholders to resolve technical queries w.r.t. regulatory requirements
Artwork Checking & development for registration and commercial purpose as per regulatory requirement
To Maintain & Update all documentation & dossier record; to update registration status.
Requirements :
Proven work experience as a Regulatory Affairs skilled.
Familiarity with product lines
Knowledge of MS Office
Excellent communication, negotiation and sales skills
Highly motivated and target driven with a proven track record.
Robust organisational and time management skills
📌 Executive / Sr Executive Mumbai
🏢 Acme Services
📍 Mumbai