Regulatory Affairs Manager

Maternity leave position

Key Responsibilities:

• Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
• Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate
• Collaborative working together with other functions (eg. marketing, supply chain) to deliver agreed New Product Launches
• Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business
• Maintain high level of Regulatory knowledge in main legislative parts (Eurasian Economic Union, Law on Drug Circulation etc) and awareness in other relevant areas like Pricing management as well as on the science of products within defined portfolio

Requirements:

• Degree in Pharmacy
• Minimum of 3 years proven experience in Regulatory Affairs

• Diverse problem solving with limited information available to make decisions and interpretations. Anticipates medium/long-term future issues
• Ability to effectively communicate and negotiate in relation to technical information and regulations is a key
• Fluency in English