Hiring For Team Leader / Asst. Manager – Drug Regulatory Affairs

5 - 10 Years

Job Description

Key Accountabilities :

1. Having good exposure of preparation & submission of dossiers for generic drug product applications for regulated markets Europe, UK, Australia & Canada.
2. Hands on experience of responding to Regulatory Agency's deficiency letters for renewals for markets Europe, UK, Australia & Canada.
3. Liaison with cross functional teams & providing regulatory support during development to final submission.
4. To mentor & train qualified associates on various Regulatory Process & submission.
5. Having good exposure of drafting & review necessary cover letter, forms & various submission documents.

Salary: Not Disclosed by Recruiter

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

Please refer to the Job description above


UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile

Gracure Pharmaceuticals Limited

Gracure Pharmaceutical Ltd. is a pharmaceutical company, established in 1992 by Mr. A.S Bhargava with the vision of making world class affordable medicines. Gracure is a research driven forward looking pharmaceutical company with expertise in development of various finished dosage. Since its inception in 1992, Gracure pharmaceuticals Ltd. has been focused to manufacture an extensive spectrum of pharmaceutical formulation products.
We engage in the research, development, manufacturing, sourcing, marketing, and distribution of high-quality pharmaceutical products. We are a fully integrated company with in-house business development, R&D, manufacturing and regulatory compliance capabilities.
Gracure Pharmaceuticals is EU-GMP & TGA Australia approved manufacturing unit.
Our manufacturing capabilities include solid orals (coated tablets, uncoated tablets, hard gelatin capsules), liquids (syrup, suspension), dry syrups (dry powder syrups), external preparations (gels, creams, ointments).
View Contact Details+

Recruiter Name:Samata Yadav

Contact Company:Gracure Pharmaceuticals Limited