Regulatory Affairs Specialist
hace 2 semanas
PMFarma is a multinational company specializing in health supplements and bio ingredients.
Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Barcelona. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our products with relevant regulations and guidelines.
Key Responsibilities- Regulatory Dossier Preparation and Submission: Prepare, submit, monitor, and update regulatory dossiers for our products and business partners in various territories.
- Regulatory Document Preparation: Create high-quality regulatory documents, including novel food, enzymes, GRAS, and other relevant submissions, in compliance with regulatory requirements.
- Response to Authority Questions: Prepare responses to questions from authorities resulting from the submission of regulatory dossiers.
- Stakeholder Communication: Communicate with internal stakeholders, including R&D and quality assurance, to collect information necessary for regulatory file completion and responses.
- Documentation Submission: Submit documentation to relevant platforms, such as Health Canada, EU Commission, and FDA, as required.
- Data Audits and Gap Analysis: Perform data audits and gap analysis to identify necessary studies, tests, and data for regulatory approval and create reports accordingly.
- Regulatory Positioning: Participate in recommendations for product regulatory positioning, risks, and opportunities.
- Regulatory Strategies: Assist the Regulatory Director in building regulatory strategies and roadmaps with pathways, costing, and timelines to market.
- Regulatory Monitoring: Monitor changes in regulations and stay updated with guidance documents in relevant countries.
- Team Collaboration: Collaborate with other members of the regulatory affairs team on global projects.
- Regulatory Compliance: Perform regulatory checks on claims, marketing messages, and technical documentation to ensure compliance with main regulations.
- Document Creation: Create various documents in Word, Excel, and PowerPoint for internal presentations and meetings.
- Document Classification: Classify and update various documents and databases.
- Education: Sc. or M.Sc in food science (microbiology, biotechnology, biochemistry, or another relevant field).
- Experience: + 2 years of experience in regulatory affairs and dossier submission.
- Regulatory Knowledge: Knowledge of the US & EU food regulatory frameworks.
- Language Skills: Excellent technical/dossier writing skills in English and advanced level of English language.
- Soft Skills: Attention to detail, good team player, can-do attitude, fast learner, flexible, problem-solving, and ability to work on multiple and simultaneous projects.
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