Regulatory Affairs Executive

2 days ago

Masjid Mumbai Maharashtra, India Amico Formulations LLP Full time

**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

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