Regulatory Affairs

5 days ago

Mumbai Maharashtra, India Sensys Technologies Pvt. Ltd Full time

**Job Summary**:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The

requirements for our products, managing the submission process for regulatory

approvals, and maintaining up-to-date knowledge of regulatory changes.

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 knowledge of Regulatory Research

Must be familiarity with chemical industry specific regulations and guidelines.

**Needed someone who are min 9 to 10 Yrs experience in regulatory affairs API Pharma.**

**Have experience of Countries USA, Canada, South Korea, South Africa, Saudi Arabia, Egypt.**

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

Pay: ₹400,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

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