Registratie Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.
Providing treatments within ophthalmology, rheumatology, pulmonology, nephrology, and neurology.
- Clinical development / support during the introduction of a product
- Maintain the life cycle management of the clients existing products
- Create and manage product information/labelling text for templates
- Develop project requirement specifications and manage all aspects of the project work
- Maintaining regulatory files and records of contact with Regulatory Authorities
- Maintain up-to-date knowledge of relevant regulations EU and US
- A minimum of 10 years’ experience in regulatory affairs in a pharmaceutical or biotech industry
- SOP / GCP / GMP
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Experience with therapeutics such as gene, biologics, vaccines, and nuclear medicine
- Good experience with demonstrated people management
- Excellent communication skills in Dutch and English
The Company
A Multinational pharmaceuticals leader, manufacturing specialty pharmaceuticals and therapies.Providing treatments within ophthalmology, rheumatology, pulmonology, nephrology, and neurology.
Role Description
As a regulatory affairs manager you will be responsible for ensuring that products meet legislation to control safety and usefulness of the product from the early stages to bringing together for approval and registration.Responsibilities
- Support the execution of global registration and regulatory strategy- Clinical development / support during the introduction of a product
- Maintain the life cycle management of the clients existing products
- Create and manage product information/labelling text for templates
- Develop project requirement specifications and manage all aspects of the project work
- Maintaining regulatory files and records of contact with Regulatory Authorities
- Maintain up-to-date knowledge of relevant regulations EU and US
Requirements
- Master degree (or higher) in a scientific field- A minimum of 10 years’ experience in regulatory affairs in a pharmaceutical or biotech industry
- SOP / GCP / GMP
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Experience with therapeutics such as gene, biologics, vaccines, and nuclear medicine
- Good experience with demonstrated people management
- Excellent communication skills in Dutch and English
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