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Title
Text copied to clipboard!Regulatory Affairs Associate
Description
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We are looking for a Regulatory Affairs Associate to join our team and support our regulatory compliance efforts. In this role, you will be responsible for assisting in the preparation, review, and submission of regulatory documents to ensure our products meet all applicable laws and standards. You will work closely with cross-functional teams, including research and development, quality assurance, and manufacturing, to gather necessary information and maintain up-to-date records. The ideal candidate will have a keen eye for detail, strong organizational skills, and a solid understanding of regulatory requirements in the healthcare, pharmaceutical, or medical device industries. Key duties include monitoring regulatory changes, maintaining regulatory files, supporting audits and inspections, and communicating with regulatory agencies as needed. You will also help interpret regulations and provide guidance to internal teams to ensure ongoing compliance. This position offers an excellent opportunity to develop your regulatory expertise and contribute to the safe and effective delivery of products to market.
Responsibilities
Text copied to clipboard!- Assist in preparing and submitting regulatory documents to authorities
- Monitor and interpret regulatory changes and updates
- Maintain accurate and organized regulatory files and records
- Support internal and external audits and inspections
- Collaborate with cross-functional teams to gather required information
- Communicate with regulatory agencies as needed
- Review product labeling and promotional materials for compliance
- Provide regulatory guidance to internal stakeholders
- Track and report on submission statuses and deadlines
- Help develop and implement regulatory strategies
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, pharmacy, or related field
- 1-3 years of experience in regulatory affairs or compliance
- Familiarity with regulatory guidelines (FDA, EMA, etc.)
- Strong attention to detail and organizational skills
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team
- Proficiency in Microsoft Office and document management systems
- Analytical and problem-solving abilities
- Ability to manage multiple projects and deadlines
- Experience in healthcare, pharmaceutical, or medical device industry preferred
Potential interview questions
Text copied to clipboard!- What experience do you have with regulatory submissions?
- How do you stay updated on regulatory changes?
- Describe a time you supported an audit or inspection.
- What regulatory guidelines are you most familiar with?
- How do you ensure accuracy in documentation?
- Can you provide an example of interpreting a complex regulation?
- What tools or systems have you used for document management?
- How do you prioritize multiple regulatory projects?
- Describe your experience working with cross-functional teams.
- Why are you interested in regulatory affairs?
