Regulatory Affairs Executive

2 weeks ago

Goregaon East Mumbai Maharashtra, India Meliorate Health Pvt Ltd Full time

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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