* Multinational Company | Career development opportunity
Multinational company specialized in health supplements and bio ingredients.
Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:
* The preparation, submission, monitoring, and updating of regulatory dossiers.
* Preparing high-quality regulatory dossiers (novel food, enzymes, GRAS, etc.) needed for the marketing of our products or those of our business partners in different territories, in compliance with relevant regulations and guidance documents.
* Preparing responses to questions from authorities resulting from the submission of the regulatory dossiers.
* Communicating with various internal stakeholders (R&D, quality assurance, etc.) for the collection of information necessary to complete regulatory files and responses.
* Submitting documentation to the corresponding platforms of the Food Authorities (Health Canada, EU Commission, FDA, others), when needed.
* Performing data audits and gap analysis to understand which studies, tests, and data are needed for regulatory approval and making reports accordingly.
* Participating in the recommendations for product regulatory positioning, risks, and opportunities.
* Assisting the Regulatory Director in building regulatory strategies and roadmaps with pathways, costing, and timelines to market.
* Monitoring changes in regulations and keeping updated with guidance documents in the relevant countries.
* Collaborating with other members of the regulatory affairs team on global projects.
* Performing the regulatory check of claims, marketing messages in advertising, marketing material, technical documentation, and videos to ensure compliance with main regulations.
* Creating various documents in Word, Excel, and PowerPoint for internal presentations and meetings.
* Carrying out the classification and updating of various documents and databases.
Solid career opportunities.
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