Regulatory Documentation Executive

4 days ago

Haridwar, India PYRAX DENTAL Full time

**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.

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

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