Regulatory Affairs Executive
2 weeks ago
**Job Summary**:
The Regulatory Affairs Specialist will be responsible for ensuring that the company's products comply with all relevant regulations and standards. This role involves preparing and submitting documentation to regulatory agencies, maintaining compliance, and staying updated on regulatory changes.
**Key Responsibilities**:
- **Regulatory Compliance**: Ensure that products comply with all applicable regulations and standards.
- **Documentation**: Prepare, compile, and submit regulatory documentation to agencies.
- **Communication**: Liaise with regulatory agencies regarding submissions, compliance issues, and audits.
- **Monitoring**: Track and analyze regulatory changes and trends to ensure ongoing compliance.
- **Review**: Evaluate product promotional materials, labeling, and specifications for regulatory compliance.
- **Support**: Provide regulatory guidance to internal teams during product development and lifecycle management.
- **Training**: Develop and deliver training on regulatory requirements and compliance procedures.
**Qualifications**:
- **Education**: Bachelor’s degree in Science or a related field.
- **Experience**: Minimum of 3-5 years of experience in regulatory affairs or a related role.
- **Technical Skills**: Proficiency in regulatory submission software and tools, and familiarity with regulatory guidelines (e.g., FDA, EMA).
- **Analytical Skills**: Strong analytical and problem-solving skills with attention to detail.
- **Communication Skills**: Excellent verbal and written communication skills to effectively interact with regulatory bodies and internal teams.
- **Organizational Skills**: Strong organizational skills with the ability to manage multiple projects and deadlines.
**Preferred Qualifications**:
- **Advanced Degree**: Master’s degree in a related field.
- **Certifications**: Relevant certifications (e.g., Regulatory Affairs Certification (RAC)).
- **Experience with Global Regulations**: Familiarity with international regulatory requirements and standards.
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