REGULATORY AFFAIRS SPECIALIST - RESEARCH & DEVELOPMENT

Job Summary

Regulatory Affairs roles require a blend of technical and soft skills. Strong analytical and problem-solving abilities are crucial for interpreting regulations and addressing complex issues. Effective communication, including writing and presentation skills, is essential for interacting with regulatory bodies and internal teams. Additionally, strong skills are needed to coordinate submissions and ensure compliance with deadlines.

Responsibilities

• Interpret regulations and address complex issues with strong analytical and problem-solving abilities.
• Communicate effectively, including writing and presentation skills, for interactions with regulatory bodies and internal teams.
• Coordinate submissions and ensure compliance with deadlines.
• Ensure a company's products and operations comply with relevant regulations, laws, and guidelines.
• Monitor regulatory changes, prepare and submit documents to regulatory agencies, and provide guidance to internal teams on compliance.
• Assess compliance, recommend remediation, and act as liaison between the company and regulatory agencies.
• Prepare and submit various documents, including product registration dossiers, clinical trial documentation, Endorsement approval COPP product wise approval and other regulatory submissions.
• Coordinate external audits with external regulatory agencies and maintain awareness of regulatory guidelines.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.