Regulatory Affairs Executive

2 weeks ago

Mohali Punjab, India Enorme Life Sciences Pvt Ltd Full time

**Job Summary**:
The Regulatory Executive will be responsible for overseeing and ensuring that all food compliance mandates related to FSSAI and AYUSH formulation guidelines are strictly adhered to.

This includes managing compliance for Enorme Lifesciences product range, which covers Proprietary Foods, Nutraceuticals, Health Supplements, Food for Special Dietary Users (FSDU), Food for Special Medical Purposes (FSMP).

The role ensures smooth regulatory operations for both new and existing products in the domestic market.

**Application Filings**: Supervise and ensure the timely preparation, review, and submission of relevant documents (e.g., artwork, labeling compliance, statements) to regulatory authorities for the issuance of new licenses or modification of existing licenses, as per FSSAI, Legal Metrology.

**Labelling Compliance**: Product & Labelling compliance for the product as per regulatory norms. Understanding and implementation to FSSAI Act, Rules & Regulations.

**Query Resolving**: Ensuring compliance of labels with regulatory requirements. Scrutinizing NPD according to latest regulatory guidelines. Preparing and maintaining various documents for regulatory submission processes. Monitoring and adhering to changing regulatory requirements and provide suggestions for implementing necessary actions.

**Regulatory Intricacies**: Maintaining up-to-date knowledge of relevant regulatory updates, including Acts, Regulations, Orders, Notices.

**Annual Return Filing**: Filing of Annual Return including Commercial Labels, FP CoA, FP MoA/ FP STPs, FP Specifications, Total Sale in a FY both in terms of value and amount of the manufactured products, both domestic and export purpose.

**New Product Development**:Checking the feasibility status of the new products in the pipeline or proposed formulations as per the FSSAI regulations/ notifications/ orders.

**Experience**:

- Food safety: 3-5 years (preferred)
- HACCP: 3-5 years (preferred)
- QA/QC: 3-5 years (preferred)
- Food industry: 5 years (preferred)

**Skills**:

- Excellent written and verbal communication skills.
- Strong organizational and project management abilities.
- Attention to detail and ability to work under tight deadlines.
- Proficiency in regulatory submission software and document management systems.

Pay: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Day shift

Supplemental Pay:

- Performance bonus

**Education**:

- Bachelors / Master's (Food Technology) (required)

**Experience**:

- USFDA regulations: 1-2 years (preferred)
- Complaint handling: 1-2years (preferred)
- HACCP: 1-2 years (preferred)

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

Pay: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Provident Fund

Schedule:

- Day shift
- Fixed shift
- Morning shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Work Location: In person

Application Deadline: 05/03/2025

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