Regulatory Affairs Manager

International pharmaceutical company Dr. Reddy's Laboratories announces vacancy of Regulatory Affairs Manager.

Responsibilities

• Preparation of registration dossiers, their renewal and variations to registration in order to ensure timely regulatory submission.
• Pre- and post- registration artwork, PIL, AND, state inspection documentation and communication of relevant registration documents, queries from MoH with corporate office; along with relevant support to GMP and QC team at Ukraine.
• Review of draft regulatory documents on their correctness.
• Communicate and follow-up with RA service agencies and vendors in order to receive samples and standards for registration purposes.
• Receive samples and standards for registration purposes.
• RA support operations in order to ensure optimum and smooth regulatory functioning.

Requirements

• Higher education preferably in medicine, pharmacy, chemistry.
• Work experience from 3 years on the preparation of registration documents, technical work related to the preparation of registration materials, interaction with the company's head office in support of the registration process.
• ability to quickly and correctly make decisions in difficult situations related to production and import, stress resistance, teamwork skills.
• Basic knowledge of Pharma industry, Pharma registration process, Ukrainian regulatory requirements.
• English - upper-intermediate level; Russian and Ukraine - fluent.

Company offers the following compensation & benefits

• Work in friendly environment with professional team.
• Professional development opportunities.
• Competitive compensation and benefits package
• Working hours: Mn-Fr, 8.30-17.30.

Please provide your application in English.