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.
For more information, please call: +373 68898408. E-mail: bb90@search4staff.com
+373 68898408