Regulatory Affairs Executive

1 day ago

Goregaon East Mumbai Maharashtra, India Meliorate Health Pvt Ltd Full time ₹ 3,00,000 - ₹ 4,00,000 per year

We Meliorate Health would like to introduce ourselves as a registered Healthcare product manufacturer in Mumbai, India. Our products are, pharmaceutical formulation, food supplementary products & herbal products. We aim to provide one stop service center for all our global partners for hospital & medical needs. We have a nutraceutical manufacturing facility at Ahmednagar, Maharashtra. To know more about us kindly go through our website . We Meliorate Health are pleased to inform you that our company is offering Regulatory Affairs Executive designation to B. Pharm/M. Pharm candidates. Please read the JD mentioned below for more details about the role.

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:

CO-ordinate with FDA documentation department to apply for product approvals, COPPs, FSCs or any tender documents.

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, ₹400,000.00 per year

Benefits:

  • Commuter assistance
  • Internet reimbursement
  • Leave encashment

Education:

  • Bachelor's (Required)

Experience:

  • total work: 1 year (Required)

Location:

  • Goregaon East, Mumbai, Maharashtra (Required)

Work Location: In person

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