Regulatory Affairs Executive

7 hours ago

Dongri Mumbai Maharashtra, India approach Full time

Designation: Executive - Regulatory Affairs

Location: Sandhurst Road, Mumbai

Department: API (Active Pharmaceutical Ingredients)

Products Handled: Pharmaceutical API, Veterinary API

Job Responsibilities:
Regulatory Documentation:
Prepare, review, and submit DMFs (Drug Master Files), CEPs, and other regulatory documents for Pharmaceutical and Veterinary APIs.

Ensure compliance with international regulatory guidelines (FDA, EMA, TGA, etc.).

Regulatory Support:
Coordinate with R&D, Quality Assurance, and Production teams to gather necessary information for regulatory submissions.

Respond to queries from regulatory authorities and customers in a timely manner.

Compliance Management:
Monitor and maintain compliance with evolving global regulatory requirements for APIs.

Perform gap analysis on regulatory documentation and propose corrective actions.

Audits and Inspections:
Assist in regulatory audits and inspections by providing the required documentation.

Address findings from audits and ensure timely resolution.

Liaison:
Communicate with clients and regulatory agencies to manage approvals and maintain good working relationships.

Record Maintenance:
Maintain updated records of regulatory submissions and approvals.

Ensure proper archiving of documents as per regulatory standards.

for any queries please feel free to contact.

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

Pay: ₹216,159.58 - ₹676,989.01 per year

**Benefits**:

- Provident Fund

Schedule:

- Morning shift

**Experience**:

- total work: 2 years (required)

Work Location: In person

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