Head of Regulatory Affairs & Pharmacovigilance Animal Health (f/m/d)
As of now we are seeking a highly experience leadership personality as Head of RA & PV for our Animal Health RCV Department (Regional Center Vienna) to join at BI’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 (LCM) activities in the region of RCV.
Thus, you are responsible for Pharmacovigilance (PV) of the Animal Health products in RCV including training of all employees on PV responsibilities.
You will account for contributing to the successful development of the Animal Health business by executing global and regional Regulatory Affairs (RA) strategies as well as managing local RA and Pharmacovigilance (PV) requirements and needs.
Tasks & responsibilities
- Lead, coordinate and manage the different requirements by enabling the professional team members and ensure alignment with Global & Regional RA strategy, priorities and targets
- Translate the Global Animal Health Regulatory Affairs Strategy into a regional strategy, representing the RA needs and local business-related RA priorities and responsible for maintaining and updating the Global databases
- 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 the BI AH authorized in ROPU
- Responsible for correct implementation of all internal and external Drug safety objectives, monitoring compliance with the legal framework required for the marketing of veterinary medicinal products (submission of updates, designations, notifications from and to the surveillance authorities)
- Lead, coach and develop team members to ensure optimal individual/team performance
- Accountable for the compliance of assigned projects, managing the LCM activities in compliance with existing legislation and policies
- Responsible for an effective and efficient information transfer and communication with relevant internal and external stakeholders as well as support of the AH industry association via Corporate or local RA Managers
- Min. Master’s degree (e.g. MBA, MSc.) or in Veterinary Medicine, Pharmacy or Human Medicine in combination with 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, pharmaceuticals, and nutraceuticals)
- Experience in local and/or European Pharmacovigilance of animal health products
- Strong communication skills along with excellent interpersonal skills and demonstrated ability to develop stakeholder relationships
- Ability to lead and coordinate diverse groups of professionals, demonstrated solid decision making & negotiation skills as well as strategic thinking, initiative, creativity, and proven track record for innovation.
- Business Fluency in English
- 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
Why Boehringer Ingelheim?
- Breakthrough therapies and innovative healthcare solutions for both humans and animals
- As a family owned company, we take the long view and stand for stability and sustainability
- Talented and ambitious teams, living innovation and growing together
- 52,000 employees globally, 2,600 in Vienna
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
Effects of Covid-19
We will continue to hire talented people and we look forward to receiving your applications. For applicants, virtual video interviews will initially take place. During the limited in-person interviews we still have during this time, we pay special attention to distance and the recommended hygiene rules. We warmly welcome new employees to our 3-day onboarding event, which takes place in the form of an online event.
We are looking forward to receiving your application online!
By uploading your application documents via our application portal we can treat your data confidentially and in compliance with the GDPR.
Ready to contact us? Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Matthäus Vogel.
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