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Title
Text copied to clipboard!Regulatory Affairs Specialist in Pharmaceuticals
Description
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We are looking for a Regulatory Affairs Specialist in Pharmaceuticals to join our team and ensure compliance with all national and international regulatory requirements related to the development, manufacturing, and marketing of pharmaceutical products. In this role, you will work closely with quality, R&D, manufacturing, and marketing teams to guarantee that all products and processes meet current laws and regulations. Your main tasks will include preparing and submitting documentation to regulatory authorities, monitoring legislative changes, participating in audits and inspections, and providing expert advice on regulatory matters. You will be responsible for maintaining up-to-date knowledge of the requirements of the European Medicines Agency (EMA), the Bulgarian Drug Agency (BDA), and other relevant institutions. Additionally, you will participate in the development of internal policies and procedures to ensure compliance with regulatory standards. The ideal candidate holds a university degree in pharmacy, chemistry, biology, or a related field, excellent communication skills, and experience working with regulatory authorities. The ability to analyze complex information, attention to detail, and the ability to work under pressure are essential. If you are passionate about the pharmaceutical industry and want to work in a dynamic and responsible environment, this position is for you.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documentation
- Communicate with national and international regulatory authorities
- Monitor legislative changes
- Participate in audits and inspections
- Develop internal policies and procedures
- Ensure compliance with EMA and BDA requirements
- Train staff on regulatory matters
- Maintain a regulatory information database
- Assist in resolving regulatory issues
- Prepare reports and analyses
Requirements
Text copied to clipboard!- University degree in pharmacy, chemistry, biology, or a related field
- Minimum 2 years of experience in a similar position
- Excellent knowledge of pharmaceutical regulatory framework
- Good communication and organizational skills
- Proficiency in English
- Ability to work in a team
- Attention to detail
- Analytical thinking
- Ability to work under pressure
- Computer literacy
Potential interview questions
Text copied to clipboard!- What is your experience with regulatory authorities?
- Have you worked with EMA or BDA?
- How do you handle changes in legislation?
- What are the main challenges in regulatory affairs?
- What documents have you prepared for regulatory purposes?
- How do you keep your knowledge up to date?
- How do you respond to audits and inspections?
- What motivates you to work in the pharmaceutical industry?
- What software tools do you use?
- How would you train a new colleague on regulatory matters?
