Regulatory Affairs Manager or Senior Specialist - Russian Speaker (home-based)

To our lifecycle management team we are looking for Regulatory Affairs Manager that will support activities on Russian market. This is an individual contributor role that requires native/fluent Russian language knowledge and solid experience in post approval regulatory affairs in Russia.

Main Responsibilities

• Acts as a Regulatory Lead on complex projects, which may include technical writing or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
• Competently writes regulatory and technical documents with minimal review by senior staff.
• Establishes relationships with customers and stakeholders; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognized and challenges when appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
• May write new regulatory standard operating procedures, and propose revisions or act as reviewer for regulatory standard operating procedures.
• Manages meetings with Regulatory Agencies.

Qualifications

• Bachelor's or Master's Degree Degree in Life Science or related discipline
• At least 5 years relevant experience in lifecycle management regulatory affairs for Russian market
• Native (preferred) or fluent in Russian language
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
• Expert in planning and delivering work on time keeping quality parameter in mind.
• In depth knowledge of regulatory procedures and intelligence in Russia
• Ability to work closely with client regional heads to determine the Regulatory, Publishing & submission strategy and execute project plan.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
• Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, CMC and publishing projects.
• Project leadership experience.
• Ability to adapt quickly to a rapidly changing environment.
• Russian language on level C1 and above

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