В крупную фармкомпанию Teva Pharmaceuticals открыта вакансия Regulatory Affairs Director.
RA Director for Russia & Eurasia is responsible for leadership in the creation and implementation of strategic processes of normative regulation.
Manages all regulatory activities in the sub-region for all products, including: generic, branded generics, innovative/specialty, OTC, vitamins, nutritional supplements, medical devices, and other products.
General duties and responsibilities:
- Develop, maintain and monitor a regulatory and quality control strategy in the sub-region
- Monitoring and evaluating regulatory trends and requirements, developing an appropriate regulatory strategy and an action plan for working with them
- Assessing potential impact of new regulatory requirements on the recommended risk-management plan
- Establishing, maintaining and developing relationships with regulatory authorities, both in the industry and among professional associations:
- To ensure a dialogue during the registration process, strategic influence on the Russian pharmaceutical sector and the healthcare industry;
- To identify local authoritative leaders and, if necessary, represent the company in the relevant areas and associations (pharmaceutical\healthcare industry)
- Development and implementation of work instructions
General duties:
- Manage, plan and develop schedules for all regulatory activities, including pre-registration approval and post-registration approval, setting priorities. Providing recommendations on regulatory activities within the company and for third parties at the stages of product development and post-registration actions
- Manage all regulatory activities, including product registration and licensing, as well as support departments for relevant legislation, directives, and regulations matters
- Ensuring that the submitted documents comply with current requirements and regulations of health authorities
- Control dossiers’ preparation and composition for timely submission in accordance with the work plan of the regulatory division
- Liaising with Teva's local and regional management units to ensure that multiple priorities are met, global and regional best practices are implemented
- Actively share and apply strategies in the sub-region and ensure that best regional/global practices are applied where possible
- Develop multi-functional collaborative relationships across business units, global divisions, and project teams
- Build and develop the capacity and productivity of the regulatory and quality control Department
- Proactively share and apply strategies in the sub-region and ensure that regional/global best practices are implemented wherever possible
- Providing tactical and operational planning, annual, semi-annual, quarterly and monthly work plans and budgets of the Department; Controlling document flow related to regulatory budget execution in accordance with internal company policies, prepares regular reports on RA Department’s budget implementation
- People management
Qualifications:
- Knowledge of legislation and regulatory requirements regulating the activities of pharmaceutical companies
- Knowledge of industry standards and guidelines governing the activities of pharmaceutical companies
- Knowledge of policies, procedures, guidelines and other local regulations that determine the activity of RA Department
- Knowledge of structural mechanism of functioning of the pharmaceutical market
- Knowledge of laws, regulations and local acts regulating registration process
- Knowledge of fundamentals of foreign law applicable to the activities in the territory of the Russian Federation
- Understanding the objectives, the mission and the views of the Company, its organization and goals, to have strategic thinking, analysis of changing regulatory trends, legislation and requirements and to be able to adapt to them
- Experience in people management
- University degree
- Working experience in companies of pharmaceutical market for at least 5 years as the RA Director
- Fluency in English