The Regulatory Affairs Manager (m/f/d) is responsible for managing the product registration chain, ensuring compliance with regulatory authorities and Global Regulatory Affairs, maintenance of product licenses, and relevant LCM (life cycle management) activities. In this role, you will work in close collaboration with regulatory and political authorities in the target countries. In addition, the Regulatory Affairs Manager plans and manages the budget for Regulatory Affairs activities.
Duties & Responsibilities
- Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the countries as well as stakeholders and influencers
- Responsible for maintaining and updating the global RA databases
- Manage product registration activities in accordance with corporate policies and according to the particularities and legislation required by country
- Action plan with the business areas, regional/ Global RA, monitor the implementation of this plan
- Responsibility for the management of LCM activities in compliance with the existing legislation and policies, representing the regulatory needs and priorities of local business
- University degree (preferably DVM, or degree in life sciences)
- Profound experience working in Regulatory Affairs in the pharmaceutical industry (human or animal health)
- Track Record of working in close collaboration with regulatory and political authorities
- Experience with product registration within CEE countries and internationally where needed as well as with EEU, CIS Regularity environment
- Experience working in culturally diverse teams, project management skills and detail orientation
- Fluency in Russian and English is required
Position specific training opportunities for your personal and professional growth
Comprehensive health promotion, sustaining your health in the best possible way
Additional off-days (bridge-days) for more leisure time
Company pension scheme, because your future matters
Staff restaurant with a variety of lunch options for your daily well-being
We offer an attractive salary package in line with your qualification, experience and individual competencies. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 50,000 gross per year/full-time).
Who we are
At Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
Your HR Recruiting Manager for this Position is Matthäus Vogel.
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