Regulatory Representative

1 day ago

Navrangpura Ahmedabad Gujarat, India VANSHIKA ENTERPRISES Full time

**Fluent in English**

**Immediate Joiner**

**Experience: Minimum 3 years**

The Regulatory Representative is responsible for ensuring compliance with all relevant regulations and standards in the development, manufacturing, and marketing of the company's products. This role involves preparing and submitting documentation for regulatory approvals, monitoring regulatory changes, and advising the company on regulatory strategies and requirements.

**Key Responsibilities**:

- Prepare and submit regulatory documents to relevant authorities (e.g., FDA, EMA) for product approvals, renewals, and variations.
- Ensure all submissions comply with applicable regulations and guidelines.
- Monitor and interpret regulatory requirements and ensure company compliance.
- Maintain knowledge of current and future regulations, guidelines, and standards.
- Conduct internal audits and assessments to ensure ongoing compliance.
- Maintain and update regulatory documentation, including technical files, product labels, and marketing materials.
- Generate and review reports, regulatory dossiers, and other documentation as required.
- Work closely with other departments, including R&D, Quality Assurance, Manufacturing, and Marketing, to provide regulatory guidance and support.
- Participate in project teams to ensure regulatory requirements are integrated into product development plans.
- Develop and implement regulatory strategies to facilitate product development and approval processes.
- Advise on regulatory aspects of new product development and market entry.
- Provide training to company staff on regulatory requirements and best practices.
- Stay updated on industry trends and developments and disseminate relevant information within the organization.
- Liaise with regulatory authorities and external consultants to ensure timely resolution of regulatory issues.
- Represent the company at regulatory meetings, industry conferences, and seminars.

**Job Types**: Full-time, Permanent

Pay: ₹50,000.00 - ₹60,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Experience**:

- total work: 5 years (preferred)

Work Location: In person

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