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Title
Text copied to clipboard!Regulatory Affairs Coordinator
Description
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We are looking for a detail-oriented and proactive Regulatory Affairs Coordinator to join our compliance team. In this role, you will be responsible for supporting the preparation, submission, and maintenance of regulatory documents to ensure compliance with local, national, and international regulations. You will work closely with cross-functional teams including quality assurance, research and development, and legal departments to ensure that all products meet applicable regulatory requirements.
The ideal candidate will have a strong understanding of regulatory processes and documentation, excellent organizational skills, and the ability to manage multiple projects simultaneously. You will play a key role in ensuring that our products are approved for market release and remain compliant throughout their lifecycle. This position requires a high level of accuracy, attention to detail, and the ability to interpret and apply regulatory guidelines.
Key responsibilities include compiling and submitting regulatory filings, maintaining regulatory databases, tracking submission timelines, and communicating with regulatory agencies. You will also assist in the development of regulatory strategies and provide support during audits and inspections. Your contributions will directly impact the company’s ability to bring safe and effective products to market in a timely manner.
This is an excellent opportunity for someone looking to grow their career in regulatory affairs within a dynamic and innovative organization. If you are passionate about compliance and enjoy working in a fast-paced environment, we encourage you to apply.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documents to authorities
- Maintain regulatory files and databases
- Track and manage submission timelines
- Coordinate with cross-functional teams for documentation
- Support regulatory strategy development
- Assist in audits and inspections
- Monitor changes in regulatory requirements
- Ensure compliance with applicable laws and guidelines
- Communicate with regulatory agencies as needed
- Review product labeling and promotional materials
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences or related field
- 1-3 years of experience in regulatory affairs or compliance
- Strong knowledge of regulatory guidelines (FDA, EMA, etc.)
- Excellent written and verbal communication skills
- Detail-oriented with strong organizational abilities
- Proficient in Microsoft Office and regulatory software
- Ability to manage multiple projects simultaneously
- Experience with regulatory submissions and documentation
- Familiarity with quality systems and standards
- Ability to work independently and in a team environment
Potential interview questions
Text copied to clipboard!- Do you have experience with regulatory submissions?
- Are you familiar with FDA or EMA guidelines?
- Can you describe a time you supported a successful audit?
- How do you stay updated on regulatory changes?
- What regulatory software tools have you used?
- How do you prioritize multiple regulatory projects?
- Have you worked with cross-functional teams before?
- What is your experience with product labeling review?
- Can you provide an example of a compliance challenge you resolved?
- Are you comfortable communicating with regulatory agencies?
