Freelance Regulatory Affairs Professional

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands.

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands. You will become part of 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

 Work 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

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 requirements.
 Ability to determine whether documents meet regulatory requirements, and are consistent with the regulatory strategy.

OTHER

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.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.