Head of Regulatory Affairs

vor 3 Monaten

Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit

**The position**:
As of now we are seeking a Head of Regulatory Affairs & Pharmacovigilance for our Animal Health RCV (Regional Center Vienna) department to join at Boehringer Ingelheim´s site in Vienna. In this role you will be responsible for managing the Product Registration Chain, Compliance with all regulatory authorities and Global Regulatory Affairs, maintenance of product licenses, and relevant Life Cycle Management activities in the RCV region. Thus, you are responsible for Pharmacovigilance (PV) of the Animal Health (AH) products in RCV including training of all employees on PV responsibilities. You will account for contributing to the successful development of the AH business by executing global and regional Regulatory Affairs (RA) strategies as well as managing local RA and PV requirements and needs.

**Tasks & responsibilities**:

- Translate the Global Animal Health Regulatory Affairs Strategy into a regional strategy, representing the Regulatory Affairs needs and local business-related Regulatory Affairs priorities
- Align the regional and local regulatory strategies and issues with other businesses/functions
- Responsible for the regulatory strategy of authorization and of maintenance of authorizations for all veterinary medicinal products of Boehringer Ingelheim
- Responsible for correct implementation of all applicable internal/external safety objectives, monitoring compliance with the legal framework required for the marketing of veterinary medicinal products
- Responsible for an effective and efficient information transfer and communication with relevant internal/external stakeholders as well as support of the Animal Health industry associations via Corporate or local Regulatory Affairs Managers

**Requirements**:

- Master’s degree in Veterinary Medicine, Pharmacy or Human Medicine
- Profound leadership experience for more than 3 years in a global matrix environment
- Experience in European and non-EU regulatory affairs in veterinary industry (mandatory: vaccines and pharmaceuticals)
- Experience in local and/or European Pharmacovigilance of animal health products
- Business Fluency in English

**Your Benefits**:

- Flexible working time models/home office depending on the position
- Additional off-days (bridge-days) for more leisure time
- Staff restaurant with a variety of lunch options for your daily well-being
- Position specific training opportunities for your personal and professional growth
- Comprehensive health promotion, sustaining your health in the best possible way

The minimum gross annual salary according to the collective bargaining agreement for this position is EUR 112 861,28 (full time). For the actual salary the industry benchmark as well as your qualifications and experiences are taken into consideration.

Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Theresa Kubina.

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