REGULATORY AFFAIRS SPECIALIST - BIO INGREDIENTS

Multinational company specialized in health supplements and bio ingredients, is looking for a Regulatory Affairs Specialist based in Barcelona Detalles del cliente Multinational company specialized in health supplements and bio ingredients Descripción de la oferta Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for.
The preparation, submission, monitoring and updating of regulatory dossiers Prepare 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.
Prepare responses to questions from authorities resulting from the submission of the regulatory dossiers.
Communicate with various internal stakeholders (R&D, quality assurance, etc.), for the collection of information necessary to complete regulatory files and responses.
Submit documentation to the corresponding platforms of the Food Authorities (Health Canada, EU Commission FDA others), when needed.
Perform data audit and gap analysis to understand which studies, tests and data are needed for regulatory approval and make reports accordingly.
Participate in the recommendations for product regulatory positioning, risks, and opportunities.
Assist the Regulatory Director in building regulatory strategies and roadmaps with pathways, costing and timelines to market.
Monitor changes in regulations and keep updated with guidance documents in the relevant countries.
Collaborate with other members of the regulatory affairs team on global projects.
Perform the regulatory check of claims, marketing messages in advertising, marketing material, technical documentation, videos, to ensure compliance with main regulations.
Create various documents in Word, Excel and PowerPoint for internal presentations and meetings.
Carry out the classification and updating of various documents and databases.
Perfil del candidato The succesfull candidate should comply with the followind requirements.
Sc.
or M.
c in food science (microbiology, biotechnology, biochemistry or another relevant field) + 2 years of experience in regulatory affairs and submission of dossiers.
Knowledge of the regulatory US & EU food regulatory frameworks.
Excellent technical/dossier writing skills in English Advanced level of English language Attention to detail, good team player, can-do attitude, fast learner, flexible, problem solving, ability to work on multiple and simultaneous projects Oferta de empleo Solid career opportunities