EMEA Regulatory Professional
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 Zuid-Holland Netherlands.
The responsibility of Regulatory Professionals is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers, manage Agency questions when required and ensure post-approval activities to take place for those submissions.
Prepare submission plan based on global dispatch and country specifics
Prepare submission-ready dossier based on local regulations and country specific requirements
Assess and implement label changes
Involve specialists for specific process steps
Ability to determine whether documents meet regulatory requirements, and are consistent with the regulatory strategy.
Regulatory Strategy
Good understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
Detailed knowledge of local regulations and guidances
Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
Submissions
Ability to quickly acquire local knowledge and shift between local situations (learning agility)
Solid RA submission process knowledge; Able to interpret guidances as they apply to submissions in the countries in scope.
Knowledge of what is needed for dossier components and submissions, how to obtain regional components and understanding of timelines. Understanding of documentation
Minimum 32 hours per week available - full time preferred.
The Company
A new regional organization to handle most LOC activities led by senior regional regulatory staff, where they will handle tactical CMC Variations and Labeling Changes in the region.Role Description
The team is a virtual, dedicated team consisting of regional team members (direct reports) and other team members that work in a matrix organization.The responsibility of Regulatory Professionals is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers, manage Agency questions when required and ensure post-approval activities to take place for those submissions.
Responsibilities
Lead and facilitate LOC CMC variation / label change processes from global dispatch to kick-off of local implementation Prepare submission plan based on global dispatch and country specifics
Prepare submission-ready dossier based on local regulations and country specific requirements
Assess and implement label changes
Involve specialists for specific process steps
Requirements
Requirements. Ability to determine whether documents meet regulatory requirements, and are consistent with the regulatory strategy.
Regulatory Strategy
Good understanding of the pharmaceutical industry and regulatory experience in drug development and/or marketed products.
Detailed knowledge of local regulations and guidances
Awareness of the scientific principles (CMC, clinical and non-clinical) applicable to the specific products.
Knowledge of quality and supply chain and potential impact to regulatory procedures and status of products
Submissions
Ability to quickly acquire local knowledge and shift between local situations (learning agility)
Solid RA submission process knowledge; Able to interpret guidances as they apply to submissions in the countries in scope.
Knowledge of what is needed for dossier components and submissions, how to obtain regional components and understanding of timelines. Understanding of documentation
Other information
Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones. Occasional international travel (3-5x/year) may be required.Minimum 32 hours per week available - full time preferred.
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