Regulatory Affairs Specialist

Job Responsibilities:

• Assurance timely submissions of applications in according to regulatory plan (NDA, Renewal, Variations, EAEU compliance);
• Operate with documents translation, local Normative document preparation, PIL writing, packaging materials artworks coordination completion of the dossier;
• Ensure alignment of EAEU requirements for registration with original dossiers;
• Assurance timely update corporate regulatory databases;
• Identify areas of opportunities and risks related to regulatory activities;
• Communicate with Regulatory Authorities and prepare, agreed with RA manger appropriate answers to requests from Regulatory Authorities;
• Coordinate submissions of post-approval commitments;
• Assist in regulatory compliance activities;
• Maintain regulatory files;
• Provide timely regulatory support to GMP inspections;
• Other duties as assigned.

Requirements:

• Postgraduate or graduate in pharmacy/biology/chemistry with experience in Regulatory Affairs;
• Working experience in companies of pharmaceutical market for at least 2 years;
• In-depth knowledge of drug development process and laws, regulations and practices affecting the pharmaceutical industry;
• Fluent English.

We offer:

• Part-time employment under a civil law contract;
• Opportunities for professional development and growth.