Regulatory Affairs Manager job description
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What does a Regulatory Affairs Manager do?
The Regulatory Affairs Manager is essential in ensuring that company products comply with all regulations and standards. This role shapes the strategic direction of regulatory policies and maintains crucial relationships with regulatory bodies.
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What are the Key Responsibilities of Regulatory Affairs Manager
- Develop and implement regulatory strategies in line with company objectives.
- Lead the preparation and submission of regulatory documents.
- Maintain knowledge of regulatory requirements and industry best practices.
- Coordinate with cross-functional teams to ensure compliance with regulations.
- Monitor the regulatory landscape to anticipate changes that may affect the company.
- Review product labels and marketing materials for regulatory compliance.
- Manage regulatory inspections and audits.
- Serve as a liaison with regulatory authorities and government agencies.
- Provide guidance on regulatory affairs to product development teams.
What are the Skills and Requirements for a Regulatory Affairs Manager?
- In-depth knowledge of regulatory guidelines and legislation.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to work collaboratively with cross-functional teams.
- Attention to detail and strong organizational skills.
What are the KPIs to track for Regulatory Affairs Manager?
The Regulatory Affairs Manager's performance is evaluated through successful regulatory filings, compliance maintenance, improved response times to regulatory queries, and proactive management of regulatory risks.
Regulatory Filings
Timeliness and accuracy of document submissions.
Compliance Maintenance
Ensure continuous adherence to regulatory standards.
Risk Management
Identification and mitigation of potential regulatory risks.
Reports to
Director of Regulatory Affairs
Collaborates with
Product Development, Quality Assurance Teams
Leads
Regulatory Specialists
Are any specific tools or software required for the Regulatory Affairs Manager role?
- Regulatory Information Management Systems (RIMS)
- Microsoft Office Suite
- Document Management Systems
What is the qualification of Regulatory Affairs Manager?
Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field; 5-7 years of experience in regulatory affairs in the pharmaceutical or medical device industry.
