Regulatory Affairs Manager
Обязанности:
*Provides strategic planning and leadership of the Regulatory Affairs team - 8 employees (direct and matrix reporting).
*Ensures development and timely execution of the regulatory strategies for innovative products to support the fastest entrance to the markets across RU&CIS Cluster.
*Ensures development and timely execution of the regulatory strategies for legacy portfolio across RU&CIS Cluster.
*Provides strategic input into regulatory development programs, lifecycle management, and compliance activities.
*Supports cross-functional teams and projects with regulatory insights.
*Supports shaping of regulatory environment, advocacy and intelligence activities.
*Be the face of the organization to regulators, participates in appropriate forums and conveys the Company’s point of view on all relevant matters; represents the company in industrial associations if needed.
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Требования к опыту:
*Graduate in pharmacy/ biology/ chemistry/ engineering or medicine is preferable
*3 years+ experience in Regulatory Affairs for medical devices
*Deep and strong expertise in regulation of medical devices registration for RU&CIS countries (incl. EAEU) and international regulation (e.g. FDA, MDR etc.)
*Team management experience 1+ years (in direct subordination and/ or project team management, including remote teams and management of 3rd parties
*Project management skills
*English (verbal and written) - Upper-Intermediate+
*Expertise in general business processes execution
*Goal oriented, responsible, dedicated
*Excellent communication and negotiation skills, good in listening, good problem-solving and influential skills
Conditions:
*Competitive salary & annual bonus
*Medical and life insurance
*Meal allowance
*Fitness compensation
*Mobile allowance
*Opportunities for professional development and growth
*Provides strategic planning and leadership of the Regulatory Affairs team - 8 employees (direct and matrix reporting).
*Ensures development and timely execution of the regulatory strategies for innovative products to support the fastest entrance to the markets across RU&CIS Cluster.
*Ensures development and timely execution of the regulatory strategies for legacy portfolio across RU&CIS Cluster.
*Provides strategic input into regulatory development programs, lifecycle management, and compliance activities.
*Supports cross-functional teams and projects with regulatory insights.
*Supports shaping of regulatory environment, advocacy and intelligence activities.
*Be the face of the organization to regulators, participates in appropriate forums and conveys the Company’s point of view on all relevant matters; represents the company in industrial associations if needed.
???
Требования к опыту:
*Graduate in pharmacy/ biology/ chemistry/ engineering or medicine is preferable
*3 years+ experience in Regulatory Affairs for medical devices
*Deep and strong expertise in regulation of medical devices registration for RU&CIS countries (incl. EAEU) and international regulation (e.g. FDA, MDR etc.)
*Team management experience 1+ years (in direct subordination and/ or project team management, including remote teams and management of 3rd parties
*Project management skills
*English (verbal and written) - Upper-Intermediate+
*Expertise in general business processes execution
*Goal oriented, responsible, dedicated
*Excellent communication and negotiation skills, good in listening, good problem-solving and influential skills
Conditions:
*Competitive salary & annual bonus
*Medical and life insurance
*Meal allowance
*Fitness compensation
*Mobile allowance
*Opportunities for professional development and growth