
Senior Regulatory Specialist
2 days ago
We are seeking a seasoned Compliance Advisor to join our team. As a key member of the organization, you will play a vital role in ensuring that all projects meet the required regulatory standards.
Job Description:
- Collaborate with cross-functional teams to develop and implement compliance strategies.
- Provide expert guidance on regulatory requirements, such as GxP, GDPR, FDA, and 21 CFR Part 11.
- Conduct system validations and identify areas for improvement.
- Review and prepare validation artifacts, including test plans and risk assessments.
Requirements:
- 4-7 years of experience in compliance and validation roles.
- Strong knowledge of regulatory standards, including GxP, GDPR, FDA, and 21 CFR Part 11.
- Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, and QMS systems.
- Excellent communication and documentation skills.
Preferred Skills:
- Experience with SaaS validation, automation, and vendor audits.
- Participation in internal/regulatory audits.
- Strong documentation skills (SOPs, templates, work instructions).
Education: Any Graduate
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