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Regulatory Affairs Specialist

hace 2 meses

Barcelona, Barcelona, España ALGAKTIV A tiempo completo

Regulatory Affairs Specialist

ALGAKTIV is a biotechnology and microalgae company headquartered in Barcelona, Spain, specializing in skincare products with high-performance active ingredients.

We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. This role is crucial in ensuring that our cosmetic products comply with national and international regulations. The ideal candidate will be responsible for managing regulatory approval processes, providing support to our sales team, and ensuring compliance with biodiversity protocols.

Key Responsibilities

  1. Regulatory Compliance and Documentation Management
    • Ensure compliance with national and international regulations for cosmetic products.
    • Develop strategies to comply with Chinese and FDA regulations to facilitate product approvals.
    • Ensure compliance with the Nagoya Protocol on biological biodiversity.
    • Manage documentation required for international export and compliance with chemical legislation (Australia, China, USA, Canada, Indonesia, Japan, and others).
    • Prepare, review, and submit documentation for regulatory approvals.
    • Maintain up-to-date chemical raw material documentation, including PID, SDS, and TDS.
    • Validate regulatory references for product packaging.
    • Ensure that cosmetic claims are substantiated appropriately, considering regional needs.
  2. Support and Collaboration
    • Provide regulatory support to our sales team and customers.
    • Establish and maintain a FAQ system for common regulatory inquiries.
    • Conduct regulatory training sessions for our sales and customer teams.
    • Collaborate with R&D, Quality, and Marketing departments on new product proposals and modifications.
    • Provide technical support to ensure all products comply with regulations and quality standards.
    • Advise internal teams on regulatory requirements and changes in applicable regulations.
  3. Regulatory Knowledge and Project Management
    • Develop and maintain up-to-date regulatory knowledge affecting cosmetic products.
    • Conduct internal training programs on regulatory issues for relevant employees.
    • Coordinate regulatory projects from conception to approval.
    • Ensure compliance with deadlines and regulatory requirements.
    • Act as the main point of contact for regulatory authorities, responding to their requests and inspections.

Requirements

  • University degree in Chemical Sciences, Pharmacy, Biology, Biotechnology, or similar field.
  • Specific training related to regulatory and dermo-cosmetics is highly valued.
  • Excellent verbal and written communication skills with fluency in English. Proficiency in other languages is a plus, including Spanish.
  • Strong attention to detail and project management skills.
  • Minimum 2 years of experience in Regulatory Affairs within the active ingredients for cosmetics or cosmetics/chemical sector.
  • Knowledge of Regulation (EC) No. 1272/2008 on classification, labelling, and packaging of substances and mixtures (CLP Regulation), as well as global cosmetic regulations (Korea K-Reach, Japan CSCL, Canada NDSL, Australia, AICS, and China new regulation) would be an asset.
  • Proficiency in Microsoft Office, especially Excel.
  • You are able to operate independently and as a collaborative, flexible team member in a dynamic work environment.
  • You must be based in Barcelona and eligible to work in Spain.

About ALGAKTIV

ALGAKTIV is a biotechnology and microalgae company headquartered in Barcelona, Spain, specializing in skincare products with high-performance active ingredients.

We are passionate about creating unique formulations using high-performance active ingredients and working with skincare brands to bring innovative products to the market.

Our team is dedicated to ensuring the global success of our cosmetic products, and we are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team.

Applications will be reviewed on a continuous basis as they are received.