Regulatory Affairs Executive

3 days ago

Ahmedabad Gujarat, India Fusion Market Research Full time

_**Regulatory Affairs Manager Responsibilities**_
- Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards.
- Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization.
- Collaborate with cross-functional teams including R&D, Quality Assurance, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle.
- Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market notifications, and post-market surveillance reports.
- Liaise with regulatory authorities and act as the primary point of contact during inspections, audits, and regulatory agency interactions.
- Conduct risk assessments and develop mitigation strategies to manage regulatory risks.
- Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements.
- Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process.
- Monitor and track regulatory compliance metrics and provide regular reports to senior management.
- Maintain a thorough understanding of international regulations in relevant markets and guide the organization regarding international expansion plans.

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

Pay: ₹20,981.70 - ₹50,884.07 per month

**Benefits**:

- Health insurance
- Life insurance
- Paid sick time
- Provident Fund

Schedule:

- Day shift
- Monday to Friday
- Morning shift

Supplemental Pay:

- Joining bonus
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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