Job Description

Key Responsibilities:

Regulatory Documentation Management:

• Prepare, review, and maintain all regulatory documentation required for product registrations, including dossiers, technical files, and submission packages.
• Ensure the documentation meets the regulatory requirements of local and international regulatory bodies (e.g., FDA, EMA, CDSCO, etc.).
• Coordinate with internal departments (e.g., R&D, Quality Assurance, Manufacturing) to gather accurate product data and technical information.
• Ensure proper formatting, compilation, and submission of regulatory documents within required timelines.

Regulatory Submissions and Approvals:

• Submit regulatory filings for product approvals, licenses, and renewals to relevant regulatory authorities.
• Track and follow up on submissions and approvals, ensuring all documents are processed within the specified timelines.
• Collaborate with regulatory agencies to resolve queries and provide any additional information required during the approval process.

Compliance Monitoring:

• Monitor changes in regulatory requirements and ensure all internal documentation processes and product registrations are updated accordingly.
• Review and update product labels, packaging, and advertising materials to ensure compliance with current regulations.
• Support internal teams with regulatory audits and inspections, ensuring all documentation is available and compliant.

Record-Keeping and Documentation Control:

• Maintain an organized and easily accessible filing system for all regulatory documentation.
• Ensure all documentation is stored in compliance with company policies and industry best practices, ensuring confidentiality and data integrity.
• Regularly update and maintain regulatory submission trackers, status reports, and compliance checklists.

Cross-functional Collaboration:

• Work closely with the product development, quality assurance, and legal teams to ensure all regulatory requirements are considered throughout the product lifecycle.
• Provide regulatory guidance and support for new product development and market expansion.
• Assist with the preparation of responses to regulatory queries and post-market surveillance documentation.

Regulatory Research and Reporting:

• Stay updated on industry regulations, guidelines, and standards relevant to the company's products.
• Assist in preparing and maintaining internal regulatory compliance reports.
• Provide recommendations on regulatory strategies for new markets or product modifications based on evolving regulations.

Job Type: Full-time

Pay: ?18,000.00 - ?24,000.00 per month

Benefits:

• Cell phone reimbursement

Schedule:

• Day shift

Supplemental Pay:

• Overtime pay
• Quarterly bonus

Education:

• Bachelor's (Preferred)

Experience:

• total work: 1 year (Required)
• Regulatory reporting: 1 year (Required)

Work Location: In person

Application Deadline: 23/11/2024
Expected Start Date: 23/11/2024