Category

Description

• Ensures compliance with regulatory agency regulations and interpretations.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Involved with the preparation of necessary outlines, summaries, status reports, project reports, memos and slides.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.
• Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance requirements
• Provides regulatory guidance to product development teams and responds to product information requests.
• Performs GAP analysis of API and finished product dossier for the Russian market.
• Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products. Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with customers’ business objectives.
• Engages with local and/or regional regulatory agencies.
• Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.

• Bachelor degree from accredited college or university in science, chemistry, biology, pharmaceutical biotechnology, pharmacy, medical / scientific writing.
• At least 4+ years of regulatory affairs or related/equivalent experience
• Experience with domestic regulatory submissions is required.
• Experience with or exposure to foreign regulatory submissions

• Russian: native speaker
• English: Fluent (mandatory)

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