Full responsibility for preparation of regulatory submissions for Russian manufacturing sites registration (fill&finish and secondary packaging) which requires cross-functional collaboration with HQ and external partner
Assist to HQ and local partners in terms of audit preparation activities, reference standards and critical reagents order process
Support of analytical transfer activities
Interaction with HQ and local partner on quality related topics
GMP inspection scheduling in cross-functional collaboration with appropriate groups and HQ
Preparation of GMP application including documents request, translation verification and submission to MoIT with requests follow up
Site inspection preparation in close collaboration with site inspection management and Global Inspection management group (gap assessment, observations follow up, site pre-visit)
On-site inspection support (translation, issue management, regulatory follow up)
Post inspection management (additional materials submission, clarification of remaining questions, CAPA alignment)
Compensation is discussed individually.
Extended social package (VMI, mobile, laptop, fitness etc.).
Professional growth is one of the corporate values.
Knowledge in DP/API manufacturing, QC, QA, development and manufacturing sites audit
Regulatory Affairs experience
Good knowledge and understanding of implementing regulatory requirements, including GMP, ICH requirements, Russian and EAEU requirements
Excellent organizational, communication and interpersonal skills
Ability to work on a number of projects with tight timelines
Ability to act and mitigate critical situations
Fluent in English both verbal and written
Readiness to frequent business trips (at least once per month)
Полная занятость, полный рабочий день, у работодателя