Regulatory Affairs Executive
3 weeks ago
Designation: Executive Regulatory Affairs
Qualification: B Pharma / M Pharm
Department: Regulatory Affairs
Location: Goregaon East, Mumbai
Joining CTC: Package around 3.00 lacs to 4.00 lacs per anum
Job Responsibilities:
1) Dossier Preparation:
Preparation and review of standard dossier, ACTD, CTD, ECTD as per Country specific guideline.
2) Query Response:
Response to all dossier related queries to comply the requirement from Ministry of Health of different countries or Regulatory team from different countries.
3) FDA Department:
4) Co-ordination:
- Co-ordination with plants for arranging samples and working standards from plant as per Authority requirement.
- Co-ordination with Marketing Department and Export Department for various registration activities.
- Co-ordination with the plant and R&D for MFR and BMR required for dossier preparation.
5) Recording/Data Management:
Responsible for maintaining proper records and storing all dossiers as per company Guidelines/Policies.
6) Miscellaneous /General:
- After receipt of sample from plant further processing at HO for printing and dispatching of sample.
- Developing art works for label/carton and leaflet in co-ordination with artist /designer
- Co-ordination with customer & site for artwork finalization & approval.
- Ensuring orders to get manufacture as per approved artwork, coordinate to get print proof & pre shipment sample approval from customer.
- Arranging market samples for new product required by ADL Department to prepare quality Data.
- Work as a team with all Regulatory colleagues.
- Supervising and reviewing documentation of dispatch samples and hard copy of dossiers/Legal document (MSDS, Invoice, Non-Hazardous certificate, Covering letter, Indemnity letter and proper packing of sample).
- Supervising and reviewing of Administrative documents for Notarization, Bombay chamber of commerce, Legalization and apostille as per country specific Embassy.
- Data Surfing related to Clinical & non clinical pertaining to product as well as dossier requirement.
**Job Types**: Full-time, Permanent
Pay: ₹300,000.00 - ₹400,000.00 per year
**Benefits**:
- Commuter assistance
- Internet reimbursement
- Leave encashment
Schedule:
- Day shift
- Fixed shift
Supplemental Pay:
- Performance bonus
- Yearly bonus
**Education**:
- Bachelor's (required)
**Experience**:
- total work: 1 year (required)
**Location**:
- Goregaon East, Mumbai, Maharashtra (required)
Work Location: In person
Expected Start Date: 25/03/2025
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