Life Sciences Regulatory Professional
5 dni temu
IQVIA is a leading provider of healthcare technology and consulting solutions. We are seeking an experienced Regulatory Affairs Manager to join our lifecycle management team, supporting activities on the Russian market.
This individual contributor role requires native/fluent Russian language knowledge and solid experience in post-approval regulatory affairs in Russia. As a key member of our team, you will be responsible for acting as a Regulatory Lead on complex projects, writing regulatory and technical documents, and establishing relationships with customers and stakeholders.
Main Responsibilities:
- Act as a Regulatory Lead on complex projects, including technical writing and project management.
- Competently write regulatory and technical documents with minimal review.
- Establish relationships with customers and stakeholders, meeting face-to-face to discuss regulatory issues and present lessons learned.
- Undertake detailed review and management of budgets related to projects, ensuring revenue recognition and challenging when appropriate.
- Provide guidance to junior colleagues, including feedback on document quality and training needs.
- Presentation to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables.
- Develop and maintain regulatory standard operating procedures.
Key Requirements:
- Bachelor's or Master's Degree in Life Science or related discipline.
- At least 5 years relevant experience in lifecycle management regulatory affairs for the Russian market.
- Native (preferred) or fluent in Russian language.
- Good understanding of the Research and Development process, laws, and guidelines.
- Expert in planning and delivering work on time while maintaining quality parameters.
- In-depth knowledge of regulatory procedures and intelligence in Russia.
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