Require Research Associate - Regulatory Affairs (Pharma) in Unichem Laboratories

Unichem Laboratories has grown to become one of India’s most respected pharmaceutical companies. It is committed to delivering better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug company with an increasing focus on cutting-edge research and developed markets.
With formulations forming the core of Unichem’s business, the company also manufactures active pharmaceutical ingredients (APIs or bulk actives). In addition, it has several pharma products that address relevant and growing therapeutic areas like gastroenterology, cardiology, diabetology, psychiatry, neurology, anti-bacterials, anti-infectives and pain management among others.

Post: Research Associate - Regulatory Affairs (Pharma) - specifically Brazil / Latin American markets

Job Description:
Preparation of Dossiers, Deficiency responses, Re-Registration Dossiers for Brazil and LATAM as per the guidelines.
Co-ordination with formulation R&D, Analytical Research & Development Dept., Mfg. Unit, Packaging Development for new project plans.
Review & approval of various technical documents (Batch mfg. & packing records, Specifications & Analytical Methods, Stability studies etc.)

Candidate Profile:
A Pharmacy/Science graduate with 2-3 years experience in Regulatory Affairs - Formulations (specifically Brazil / Latin American markets). Should be self-driven, confident, possess sound technical knowledge, good communication and co-ordination skills.

Additional Information:
Exp: 2-5 years
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA