Regulatory Affairs Executive

22 hours ago

Mumbai Maharashtra, India CP HR Services Pvt.Ltd Full time

**Company Name**: Anmol Chemicals
- **Designation** **:Regulatory Affairs Specialist**
- **Qualifications**: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
- **Experience**: Minimum 2-5 years of experience in regulatory affairs
- **Salary**: Good Hike on Current CTC
- **Location**: Sandhurst Road Mumbai - Head office
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- **Job Summary**:
**Essential Duties and Responsibilities**:
Ø **Regulatory Compliance**: Ensure company products comply with relevant regulatory requirements, such as USFDA, FDA, EMA, and local regulations.

Ø **Submission Management**: Prepare and submit regulatory documents, such as INDs, NDAs, and MAAs, to regulatory agencies.

Ø **Regulatory Strategy**: Develop and implement regulatory strategies to support product development and commercialization.

Ø **Regulatory Intelligence**: Stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.

Ø **Audits and Inspections**: Coordinate and manage regulatory audits and inspections.

Ø **Labeling and Advertising**: Review and approve product labeling and advertising materials for regulatory compliance.

Ø **Regulatory Agency Interactions**: Communicate with regulatory agencies, such as the FDA, to address questions and concerns.

Ø **Regulatory Documentation**: Maintain and manage regulatory documents, such as regulatory submissions, approvals, and correspondence.

Ø **Training and Guidance**: Provide regulatory training and guidance to internal stakeholders.

Ø **Compliance Monitoring**: Monitor company activities for compliance with regulatory requirements.

**Skills**:

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

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

Pay: ₹50,000.00 - ₹65,000.00 per month

Schedule:

- Day shift

Work Location: In person

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