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Regulatory Technical Specialist
2 weeks ago
Research and interpret complex technical regulations and standards.
Translate regulatory language into actionable guidance for internal teams.
Design and implement policies, procedures, and systems to ensure regulatory compliance across the product lifecycle.
Collaborate with cross-functional teams to embed compliance into operations.
Compile and submit documentation for regulatory approvals.
Liaise with regulatory bodies to facilitate timely reviews and approvals.
Track evolving regulatory requirements and assess their impact.
Oversee post-market surveillance and safety monitoring activities.
Conduct internal audits to verify compliance with internal and external standards.
Recommend corrective actions and continuous improvement measures.
Provide regulatory guidance and training to internal stakeholders.
Serve as the primary liaison with external regulatory agencies.
Preferred candidate profile
Pharma Technical Background with min 10 Years Exp
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