Regulatory Affairs Manager | 5 months
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.
They develop, produce and sell medication, hospital products and self-care products. One in five packs in the pharmacy are from this company and that makes them the biggest supplier of medication in the Netherlands.
- Strategic planning together with the Regulatory Director
- Providing guidance to junior staff
- Reviewing of work from the junior staff
- Planning and managing Regulatory activities in accordance with health authorities
- 5 years' of working experienced within Regulatory Affairs
- In-depth knowledge and experience of SmPC, PIL, labelling updates
- Hands-on experience of safety variations and artwork reviews
- Fluent in English and Dutch
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Helene de Vries
The Company
This company is focused on filling the needs of patients, an all-round pharmaceutical company operating on national and international level.They develop, produce and sell medication, hospital products and self-care products. One in five packs in the pharmacy are from this company and that makes them the biggest supplier of medication in the Netherlands.
Role Description
This is a temporary cover during a pregnancy leave. As a Regulatory Affairs manager you will lead the group that are responsible for the development of module 1.3. With empathy for commercial processes you will plan strategics together with the Regulatory Affairs Director.Responsibilities
- Lead the Regulatory Affairs group responsible for Module 1.3- Strategic planning together with the Regulatory Director
- Providing guidance to junior staff
- Reviewing of work from the junior staff
- Planning and managing Regulatory activities in accordance with health authorities
Requirements
- Master or PhD in a relevant field- 5 years' of working experienced within Regulatory Affairs
- In-depth knowledge and experience of SmPC, PIL, labelling updates
- Hands-on experience of safety variations and artwork reviews
- Fluent in English and Dutch
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Helene de Vries
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