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Regulatory Affairs Specialist, Product Compliance
hace 2 meses
Earn a competitive salary of $75,000 - $90,000 per year, depending on experience and qualifications.
Job Description:We are seeking a highly skilled Regulatory Affairs Analyst to join our team in Mexico City. As a key member of our Regulatory Affairs department, you will be responsible for ensuring product compliance throughout the entire product lifecycle, across various categories of products, for the Mexico territory, as well as delivering core dossiers for LATAM, primarily for cosmetics and household products.
Key Responsibilities:- Report regularly to the Regional Regulatory Affairs Department with relevant KPIs, focusing on timelines, status of supporting data from other functions, and dossier preparation.
- Assist the Regional Regulatory Affairs Department in preparing submissions to Competent Authorities and Notified Bodies, guaranteeing timely approval of new products and life-cycle submissions.
- Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager in a timely manner.
- Support the submission of product dossiers, ensuring proper electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, maintaining accurate data and keeping regulatory databases and tools up-to-date for assigned products.
- Update and maintain product registration and ingredients archives, databases, and tracking tools.
- Upload and maintain technical files/dossier databases, as well as upload required documentation to support the placing of market for other categories of products (e.g., cosmetics, home care, consumer goods).
- Work closely with other regions to obtain necessary documents and information for product dossiers.
- Collect appropriate documentation to support regulatory submissions in other countries when products are cross-border sourced.
- Assist Regional Regulatory Affairs managers in creating ingredient lists for labeling purposes.
- Assist RA managers with artwork review and approval.
- Understand current regulations, guidelines, and standards relevant to ensure compliance with applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, biocides, detergents, consumer goods).
- Ensure the content, organization, and overall quality of all regulatory documents meet local/regional regulatory requirements, commitments, and agreements.
