Exe / Sr Exe – Regulatory Affairs – API – Baroda

2 - 5 Years
Not Disclosed by Recruiter
Posted: 60 days agoJob Applicants: 787Job Views: 160

Job Description

Opening for Executive / Sr. Executive - Regulatory Affairs (API)

Location: Mumbai

Education: M.Sc. (Organic Chemistry)

Experience: 3 - 6 yrs

Job Description:

Review all data and documents related to product registrations for various health authorities

Compilation of Drug Master Files, Registration Dossiers & Technical Data Packages/OpenParts for In-House developed APIs manufactured at In-House API manufacturing sites and ensuring their updation.

Prepare responses to deficiency letters received from various agencies for expeditious approval.

Preparation of Regulatory Amendments / Variations for smooth API supplies.

Provide regulatory support to cross functional departments.

Re-position of regulatory database and compliance to procedures.

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:Full Time, Permanent


Desired Candidate Profile

Please refer to the Job description above


UG:B.Sc - Any Specialization

PG:MS/M.Sc(Science) - Chemistry, Any Specialization

Doctorate:Doctorate Not Required

Company Profile

Sun Pharmaceutical Industries Ltd

From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide. Our global presence is supported by over 40 manufacturing facilities spread across six continents and R&D centres across the globe. Innovation is at the core of Sun. We have nearly 2000 scientists working in six research centers across India, Israel and USA who have a passion for innovation and longing to provide better healthcare to humanity at large.Our multi-cultural workforce, comprising over 30,000 employees from 50 nationalities, is our biggest strength. We recognize our employees¢¢ passion for growth and empower them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.
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Recruiter Name:HR Department

Contact Company:Sun Pharmaceutical Industries Ltd