Regulatory Affairs Officer / Sr.Officer - Pharma OSD - Mumbai

Job Description:

We are seeking a skilled Regulatory Affairs Officer/Sr. Officer for our OSD (Oral Solid Dosage) pharmaceutical operations. The ideal candidate will be responsible for:

Key Responsibilities:

• Preparation and review of dossiers in CTD, ACTD, and eCTD formats
• Managing queries and responses from various MOHs (Ministries of Health) and customers
• Coordinating with internal stakeholders (R&D, QA, QC, Production, Purchase, and PDD)
• Reviewing technical documents such as process validation, stability data, finished product specifications, PDR, AMV, DMF (open part), and artwork
• Coordinating the arrangement of samples for registration with various MOHs

Preferred Candidate Profile:

• Prior experience working with African, Asian, and CIS regions
• Knowledge of product launch processes at manufacturing sites
• Experience in submitting samples for export markets