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Drug Development Manager - Clinical & Regulatory Affairs / Mijdrecht
Deze vacature staat offline! | | De opdrachtgever
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Bayer is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer, is one of the world’s leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.
| | De omschrijving
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For veterinary pharmaceutical products you are responsible for clinical development and achieving approval for in-licensed products and products based on CRO-platform technologies with focus on EU.
In the clinical development you are responsible for all clinical tasks, reviewing and authorizing of studies and development activities as well as the preparation of the clinical dossier. In the registration field you are responsible for all regulatory aspects during the development necessary for achieving the registration including the preparation of the dossier. You steer the necessary Contract Research Organization (CRO) to achieve the results necessary for Development and Registration
You have multiple interfaces with several functional departments in Bayer Animal Health in the USA as well as in the head office in Germany, the CRO in the USA, and Bayer B.V. Netherlands.
Aim of the job in more detail:
- Define registrations strategies and execute accordingly.
- Prepare and execute submission to regulatory agencies.
- Manage the external resources needed to execute and perform the needed studies and prepare documents/study reports.
- Proactively work on the development of new products ideas utilizing the CRO platform Technologies.
- Contribution to novel approaches within the CRO platform technologies.
- Member of the Operating committee of CRO and contribute to operational and technical R&D
issues, to product formulation and development, manufacturing issues, protection and expansion of intellectual property.
| De eisen
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- Degree in veterinary medicine, pharmacy or biology with postgraduate qualification (Ph.D.).
- 3 of more years of experience in regulatory affairs en solid knowledge of clinical product development of veterinary products within the EU.
- Ability to work in a complex, cross-cultural environment with good networking capabilities.
- Ability to act as an entrepreneur and to work to firm deadlines in a result-oriented manner.
- Due to importance of the project for the company and the complex nature of the job the role is necessarily suited to an individual with good communication and social skills and a functionally broad understanding.
- Excellent English in speaking and writing , knowledge in Dutch desirable.
- MS office and project management tools like MS Project.
| De arbeidsvoorwaarden
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A successful and active international company, which develops and sales innovative products. The opportunity to contribute in strengthening our market position, an environment where you will have the opportunity to learn, develop your talents and an environment where your will be challenged.
| | Contactinformatie
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Dr. Arjan van den Wijngaard
Consultant Medical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 50650550 |
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Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar arjan@pharmamediair.nl.
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