Manager Regulatory Affairs
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.
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Able to articulate complex regulatory issues and support global development and commercialization of early and late state programs
• Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout Europe and ensures timelines are met
• Maintains awareness of European regulatory environment and assesses impact of changes on business and product development programs.
• Develops and implements department policies, processes and SOPs
A minimum of 8 years in the pharmaceutical industry.
Strong understanding of and experience with global medical device-drug combination regulatory approvals;
Business travel to be ~10-20% as required
The Company
The company values solving complex medical challenges in a unique field of pharmaceuticals.Role Description
Seeking a highly motivated Regulatory Affairs Manager who works with a straight forward approach. The individual acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. Externally, the individual will interact with outside regulatory agencies and business partners in regards to regulatory, and registration strategies.Responsibilities
• Uses extensive knowledge of NL and EU regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
• Able to articulate complex regulatory issues and support global development and commercialization of early and late state programs
• Oversees and/or leads as necessary the preparation and submission of documentation to support investigational and marketing registration packages throughout Europe and ensures timelines are met
• Maintains awareness of European regulatory environment and assesses impact of changes on business and product development programs.
• Develops and implements department policies, processes and SOPs
Requirements
BA/BS Degree required, preferably in a health/life sciences or related fieldA minimum of 8 years in the pharmaceutical industry.
Strong understanding of and experience with global medical device-drug combination regulatory approvals;
Business travel to be ~10-20% as required
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