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Drug Regulatory Affairs Executive

3 - 8 YearsAnand

Posted: 20 days ago

Job Description

Key responsibilities of DRA Executive

1 Preparing documents for obtaining marketing permission, COPPs, FSCs and other certificate as required from the FDCA.

2 Compilation & review of documents for dossier submissions.

3 Addressing queries received on dossiers submitted for approvals.

4 Supervising the preparation & submission of registration samples in interaction with the production and QC department.

5 Filing of the office copies of dossiers, certificates and other documents filed with regulatory authorities.

6 Preparation of PDL upon receipt of the regulatory approval.

Salary: INR Salary is no bar for right Candidates
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Permanent Job, Full Time

Desired Candidate Profile

Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required

Company Profile

Baroque Pharmaceuticals Pvt Ltd
Baroque Pharmaceuticals Pvt Ltd is a quality focused Manufacturer of Pharmaceutical Formulations based at Khambhat (Cambay), Dist. Anand, Gujarat, in India, strongly armed with a big portfolio of Oral Solid & Liquid Dosage forms spread across a wide range of therapeutic categories. We are an ISO 9001-2008 certified company with a WHO GMP Compliant manufacturing Unit and R&D Unit at a logistically convenient locations in Gujarat.
View Contact Details+
Contact Details

Recruiter Name:Kalpit Darji

Contact Company:Baroque Pharmaceuticals Pvt Ltd



Address :NH No. 8, At. Vaghasi, Tal & Dist. Anand

Reference Id:DRA Executive-001


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