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Title
Text copied to clipboard!Regulatory Affairs Manager
Description
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We are looking for a Regulatory Affairs Manager to lead and coordinate all regulatory activities within our organization. The Regulatory Affairs Manager will be responsible for ensuring that our products and business operations comply with all relevant regulations, standards, and laws. This role requires a deep understanding of regulatory requirements, excellent communication skills, and the ability to work cross-functionally with various departments such as R&D, Quality Assurance, Legal, and Marketing. The ideal candidate will monitor regulatory changes, prepare and submit documentation to regulatory agencies, and provide strategic guidance to ensure timely product approvals and ongoing compliance. The Regulatory Affairs Manager will also develop and implement regulatory strategies, manage relationships with regulatory authorities, and support audits and inspections. This position requires strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously. The successful candidate will play a key role in maintaining the company’s reputation and ensuring the safety and efficacy of our products in the market.
Responsibilities
Text copied to clipboard!- Ensure company products comply with all applicable regulations and standards.
- Prepare and submit regulatory documents to authorities.
- Monitor and interpret regulatory changes and communicate updates to relevant teams.
- Develop and implement regulatory strategies for product approvals.
- Liaise with regulatory agencies and maintain positive relationships.
- Support internal and external audits and inspections.
- Provide regulatory guidance to cross-functional teams.
- Maintain regulatory files and documentation.
- Train staff on regulatory requirements and best practices.
- Participate in risk assessments and mitigation planning.
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, pharmacy, law, or related field.
- 5+ years of experience in regulatory affairs or compliance.
- Strong knowledge of relevant regulations (e.g., FDA, EMA, ISO).
- Excellent written and verbal communication skills.
- Proven ability to manage multiple projects and deadlines.
- Attention to detail and strong organizational skills.
- Experience working with regulatory agencies.
- Ability to work collaboratively in cross-functional teams.
- Problem-solving and critical thinking abilities.
- Proficiency in regulatory submission software and tools.
Potential interview questions
Text copied to clipboard!- What experience do you have with regulatory submissions?
- How do you stay updated on changing regulations?
- Describe a time you managed a challenging regulatory issue.
- What regulatory agencies have you worked with?
- How do you ensure cross-functional teams understand compliance requirements?
- What strategies do you use to manage multiple projects?
- How do you handle tight deadlines for regulatory submissions?
- Can you describe your experience with audits or inspections?
- What is your approach to risk assessment in regulatory affairs?
- How do you maintain accurate regulatory documentation?