Regulatory Affairs Officer

3 days ago

Mumbai Maharashtra, India Orbitouch Outsourcing Pvt ltd Full time

Designation : Regulatory Affairs Specialist

Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry

Experience : Minimum 8 years of experience in regulatory affairs

Salary : As per industry

Location : Sandhurst Road Mumbai - Head office

**Job Summary**:
**Essential Duties and Responsibilities**:

- **Regulatory Compliance**: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.
- **Submission Management**: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.
- **Regulatory Strategy**: Develop and implement regulatory strategies to support product development and commercialization.
- **Regulatory Intelligence**: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.
- **Audits and Inspections**: Coordinate and manage regulatory audits and inspections.
- **Labeling and Advertising**: Review and approve product labeling and advertising materials for regulatory compliance.
- **Regulatory Agency Interactions**: Communicate with regulatory agencies, such as the FDA, to address questions and concerns.
- **Regulatory Documentation**: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.
- **Training and Guidance**: Provide regulatory training and guidance to internal stakeholders.
- **Compliance Monitoring**: Monitor company activities for compliance with regulatory requirements.

**Skills**:

- Must have good knowledge of Regulatory Submissions
- Must have good understanding of Regulatory Research
- Must be familiar with chemical industry-specific regulations and guidelines.

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

Pay: ₹1,000,000.00 - ₹1,500,000.00 per year

Schedule:

- Day shift
- Fixed shift
- Morning shift

Work Location: In person

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