Senior Regulatory Affairs Manager
Last updated: 03/07/09
My client, one of the top leading pharmaceutical companies in the world is currently looking for a Senior Regulatory Affairs Manager (veterinary medicinal products)to take responsibility worldwide for the safety and efficacy dossier within registered pharmaceutical veterinary medicinal products and products in a development stage.
Your tasks will be:
Responsibility for preparation and submission of pre-approval and of post-approval registration dossiers / documentation for pharmaceutical VMPs
Definition, evaluation and interpretation of regulatory requirements for the development of VMPs and dossier assessment
Development and realisation of registration strategies for new and registered products
Responsibility for the technical content of international Summary of Product Characteristics (SPC) for new and registered products
Responsibility to manage, coach, develop and motivate staff
Participation in departmental projects and representation of the company at internal and external functions (e.g. IFAH)
Requirements:
Degree in Life Science (Veterinarian with Ph.D. or equivalent background)
Experience in International Regulatory Affairs for ca. 5 years
Proven extensive experience in European Regulatory Affairs
Established understanding of pharmaceutical drug development
Ability to work to firm deadlines, in an independent result-orientated manner as well as in a team
Fine attention to details
Excellent written and spoken English
Sound knowledge of the MS Office Programs
My client is based near Frankfurt. This is a permanent role and candidates from the whole of Europe are welcome to apply. German language is not essential.
SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business
- Job type: Full-time
- Industry: Science
- This post has been viewed 112 times
- Link to this ad: http://jobs.justlanded.com/en/Germany/Job-Offers_Business_Other/Senior-Regulatory-Affairs-Manager-0
A constantly growing International CRO is seeking a Senior Drug Safety professional - who will be involved in managing...
Medical Drug Safety will be joining an International CRO to be responsible for strategic and operational functions of...
Company: Our client is a major Financial Services company with over €10bn in revenue. They have an EMEA Finance...
Company: Our client is a major Financial Services company with over €10bn in revenue. They have an EMEA Finance...
Trial Biostatistician – Germany, West
Highly Competitive Salary and Benefits Package
Are you looking...
Are you looking to work on exciting and challenging projects at an international and fast-growing company? Do you want...
Senior Statistician / Biostatistician – Germany
A leading pharmaceutical company has an opening for an experienced...
Statistical / SAS programmer - Germany
Job Summary:
Working for this major pharmaceutical client within their statistics...
Senior SAS / Statistical programmers - Germany
A major pharmaceutical company in Germany is currently looking for several...
Job Summary:
Working with one the largest and well respected companies in Europe, I urgently require a contractor...