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Title
Text copied to clipboard!Pharmaceutical Regulatory Affairs Specialist
Description
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We are looking for a Pharmaceutical Regulatory Affairs Specialist to join our team and ensure our products comply with applicable pharmaceutical laws and regulations. The person in this role will work closely with R&D, quality, and production departments to ensure that all products meet regulatory requirements in local and international markets.
Key responsibilities include preparing and submitting regulatory documentation for medicinal products, monitoring changes in legislation, and providing guidance on regulatory compliance. The candidate should have experience working with registration documentation, be familiar with EMA, FDA, and local regulatory requirements, and demonstrate analytical thinking and attention to detail.
The ideal candidate will have a university degree in pharmacy, chemistry, biology, or a related field, and at least 2 years of experience in a regulatory affairs department within a pharmaceutical company. Advanced English proficiency is essential, as much of the documentation and communication is conducted in English.
We offer stable employment in a dynamically growing company, opportunities for professional development, participation in international projects, and an attractive benefits package. If you are meticulous, organized, and want to have a real impact on the safety and quality of medicinal products, this offer is for you.
Responsibilities
Text copied to clipboard!- Prepare regulatory documentation for medicinal products
- Monitor changes in pharmaceutical legislation
- Collaborate with regulatory authorities (EMA, FDA, URPL)
- Provide guidance on regulatory compliance
- Work with R&D, quality, and production departments
- Participate in regulatory audits and inspections
- Update documentation in accordance with legal requirements
- Conduct regulatory risk analysis
- Train staff on regulatory requirements
- Create and update internal procedures
Requirements
Text copied to clipboard!- University degree in pharmacy, chemistry, biology, or related field
- Minimum 2 years of experience in regulatory affairs
- Knowledge of EMA, FDA, and local regulations
- Fluent in English
- Ability to work with technical documentation
- Analytical skills and attention to detail
- Good organizational and self-management skills
- Teamwork skills
- Familiarity with quality management systems
- Willingness to continuously learn and follow regulatory changes
Potential interview questions
Text copied to clipboard!- What experience do you have with registration documentation?
- Have you worked with authorities like EMA or FDA?
- What quality management systems are you familiar with?
- Do you have experience working in an international environment?
- How do you handle regulation analysis and interpretation?
- Have you participated in regulatory audits?
- What are your expectations for professional development?
- Are you comfortable working under time pressure?
- What tools do you use to track regulatory changes?
- Do you hold any certifications related to pharmaceutical regulations?
