Regulatory Affairs Specialist

WHY THIS ROLE

Why is this something for you?

Prepare, compile and submit regulatory dossiers for new product registrations across international markets
Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
Maintain and organize regulatory documentation according to country-specific regulatory requirements
Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
Contribute to improving regulatory processes, documentation and internal workflows

WHAT OTHERS SAY

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ABOUT THE TEAM

Inside

Prepare, compile and submit regulatory dossiers for new product registrations across international markets
Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
Maintain and organize regulatory documentation according to country-specific regulatory requirements
Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
Contribute to improving regulatory processes, documentation and internal workflows

ABOUT THE LOCATION

Life in Waalre

Prepare, compile and submit regulatory dossiers for new product registrations across international markets
Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
Maintain and organize regulatory documentation according to country-specific regulatory requirements
Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
Contribute to improving regulatory processes, documentation and internal workflows

WHAT MAKES IT UNIQUE

Prepare, compile and submit regulatory dossiers for new product registrations across international markets
Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
Maintain and organize regulatory documentation according to country-specific regulatory requirements
Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
Contribute to improving regulatory processes, documentation and internal workflows

BENEFITS

Prepare, compile and submit regulatory dossiers for new product registrations across international markets
Manage the full lifecycle of regulatory dossiers, including variations, renewals and updates
Take ownership of a portfolio of countries and ensure registrations remain compliant and up to date
Maintain and organize regulatory documentation according to country-specific regulatory requirements
Communicate with regulatory authorities, agents and partners regarding submissions, questions and approvals
Monitor regulatory developments and ensure product documentation remains aligned with regulatory requirements
Collaborate closely with QA, QC, logistics and sales to ensure products can be registered, released and supplied to the market
Support the transfer and maintenance of registrations when manufacturing sites or product documentation change
Contribute to improving regulatory processes, documentation and internal workflows

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