Job Description

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 www.melioratehealth.com . 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: ₹300,000.00 - ₹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