Executive / Sr Executive

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 professional.
• Familiarity with product lines
• Knowledge of MS Office
• Excellent communication, negotiation and sales skills
• Highly motivated and target driven with a proven track record.
• Strong organisational and time management skills