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Detalii -
Post vacant

Post vacant

Regulatory Affairs Specialist

Codul postului vacant: RAS

HR-Consulting Srl on behalf of its client – a beauty company, is looking for a highly professional candidate to fulfill the position of:

Regulatory Affairs Specialist

 
Main Responsibilities:
 
1. Regulatory Strategy and Compliance:
  • Develop and implement regulatory strategies to ensure that products meet all regulatory requirements and standards
  • Provide regulatory guidance to project teams during the development of new products
  • Prepare and maintain regulatory submissions, such as INDs (Investigational New Drug applications), NDAs (New Drug Applications), and MAAs (Marketing Authorization Applications)
  • Review and approve product labels, packaging, and advertising materials to ensure compliance with regulatory requirements
  • Identify potential regulatory risks and develop mitigation strategies
2. Regulatory Submissions:
  • Compile and submit regulatory documents to obtain product approvals
  • Ensure timely submissions and manage responses to regulatory inquiries and requests for additional information
  • Manage and facilitate the entire product testing and certification process to obtain trust badges for existing products 
3. Monitoring and Reporting:
  • Monitor changes in regulatory requirements, developments, guidelines, and industry standards and ensure that the company is aware of and compliant with these changes
  • Analyze and interpret regulatory requirements and communicate their impact on the company's products and processes
  • Prepare and submit periodic reports as required by regulatory authorities 
4. Contract Management:
  • Draft, review, and negotiate contracts with various partners, including agencies, factories, suppliers, and other stakeholders
  • Ensure all contracts comply with legal and regulatory requirements and align with company policies
  • Provide legal advice on contract-related issues and disputes 
5. Audit and Inspection Readiness:
  • Prepare the company for regulatory inspections and audits
  • Ensure that all necessary documentation and processes are in place to demonstrate compliance during inspections 
 
Requirements:
  • Bachelor's Degree in a relevant field such as Biology, Chemistry, Pharmacology, or a related scientific discipline
  • Minimum of 3 years of experience in regulatory affairs, preferably within the skincare, cosmetics, or pharmaceutical industry
  • Proven track record of successful regulatory submissions and product approvals
  • Deep understanding of regulatory requirements and guidelines for skincare and cosmetic products (e.g., FDA, EMA, and other international regulations)
  • Proficiency in preparing and submitting regulatory documents such as INDs, NDAs, and MAAs
  • Understanding of product labeling requirements, including INCI (International Nomenclature of Cosmetic Ingredients) and claims substantiation
  • Awareness of industry trends and changes in regulatory landscapes affecting the skincare industry
  • Attention to detail to ensure accuracy and compliance in all regulatory documents and activities
  • Advanced level of English 

 

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