Regulatory Affairs

4 days ago

Andheri Mumbai Maharashtra, India The Hiring Experts Full time

**Job Title: Regulatory Affairs for a reputed pharmaceutical company**

1. Review all technical documents for submission of ANDA submission and post-approval submissions.

2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies.

3. Preparation and review of pre-ANDA meeting packages, and controlled correspondences.

4. To track all changes from time to time in the product life cycle for ANDAs. Ensure all changes comply with current FDA thinking and expectations.

5. Preparation and review of supplements for changes in ANDA. Ensured to have post-approval compliance at risk-based assessment i.e. determining and evaluating appropriate filing categories e.g. CBE-0/CBE-30/PAS.

6. To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to the FDA with detailed change history.

7. Evaluation of change control/deviation and review of technical documents in its support. Facilitating regulatory audits along with another department of the plant.

8. To maintain an internal regulatory database with all requisite details and necessary supporting documentation to facilitate the operation of the regulatory affairs department within the organization.

**Skills Required**:
1. Well verse with ICH, US FDA and relevant guidelines

2. Strategic thinking and proactive planning

3. Awareness of job responsibilities

4. Decision-making and problem-solving

5. Mentoring and interpersonal communication6. Ability to inspire teammates and recognition.

**Experience Required: 8-12 Years**

**Qualification: M. Pharma/ B.Pharma**

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

**Salary**: ₹1,000,000.00 - ₹1,500,000.00 per year

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- total work: 8 years (preferred)

**Speak with the employer**
+91 8692970927

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