Regulatory Affairs Executive

3 weeks ago

Perungudi Chennai Tamil Nadu, India MORULAA HEALTH TECH PVT LTD Full time

Job Summary

The Regulatory Affairs Specialist is responsible for ensuring compliance with all applicable

regulations governing the development, manufacturing, and distribution of the company's

products. This role involves collaborating with internal teams and regulatory agencies to

facilitate product registrations, approvals, and adherence to quality standards.

Key Requirements:
1. Regulatory Compliance: Stay abreast of local, national, and international regulatory

requirements.

2. Interpret and communicate regulatory standards to internal teams.

3. Product Registration and Submissions: Prepare, compile, and submit regulatory

documents for product registrations and approvals. Liaise with regulatory agencies to

facilitate successful submissions.

4. Documentation Management: Maintain accurate and up-to-date regulatory

documentation, including product dossiers and submissions.

5. Ensure compliance with documentation standards.

6. Communication and Liaison: Act as the primary point of contact between the company

and regulatory authorities.

7. Respond to queries and address concerns from regulatory agencies.

8. Regulatory Strategy: Contribute to the development of regulatory strategies for

product development and market access.

9. Provide guidance on regulatory pathways for new products.

10. Quality Standards: Ensure products meet quality standards and comply with Good

Manufacturing Practice (GMP) and Good Clinical Practice (GCP) requirements.

11. Risk Assessment: Evaluate potential risks associated with regulatory compliance and

develop strategies to mitigate them.

12. Monitoring Regulatory Changes: Stay informed about changes in regulations and

industry trends.

Qualifications:
1. Doctorate of Pharmacy in a relevant field (e.g., regulatory affairs, life sciences, pharmacy).

2. Minimum 2 years of experience in regulatory affairs within the industry.

3. Knowledge of relevant regulations and guidelines.

4. Strong attention to detail and organizational skills.

5. Excellent communication and interpersonal skills.

6. Ability to work effectively in cross-functional teams.

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

**Salary**: ₹20,000.00 - ₹25,000.00 per month

**Benefits**:

- Food provided

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (required)

Ability to Commute:

- Perungudi, Chennai, Tamil Nadu (required)

Ability to Relocate:

- Perungudi, Chennai, Tamil Nadu: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**
+91 7708582768

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