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

Interested candidates may send CVs to HR-Consulting (www.search4staff.com) email address: bb90@search4staff.com. 

Please, indicate the relevant vacancy code RAS in the subject line or resume.