Regulatory Affairs Executive

Post: RA Executive

Experience: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation)

Location: Masjid Bunder, Mumbai

• Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations.
• Preparation, Compilation & Review of Registration documents that include Administrative & Technical. Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ensures them to correct the documents.
• Handling RFIs (Requested Further Information’s) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.
• Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.
• Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.
• Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.
• Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.
• Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.
• Fill up customer questionnaires by collecting information from various concerned departments.
• You should be good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
• Maintenance of the complete history of each drug product.
• Prepare and compliance of Modules-I as per regulatory requirement.

Job Types: Full-time, Permanent

Pay: ₹500,000.00 - ₹600,000.00 per year

Benefits:

• Provident Fund

Ability to commute/relocate:

• Mumbai - 400003, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• total work: 5 years (Preferred)

Work Location: In person