Regulatory Affairs (Mumbai)

Regulatory Affairs (Mumbai)

12 Aug
|
Truemeds
|
Mumbai

12 Aug

Truemeds

Mumbai

Quality & Compliance - Senior Manager

We are looking for a Quality & Compliance - Senior Manager with experience in pharmaceutical manufacturing, pharmaceutical distribution, retail pharmacy, hospital quality assurance, or the pharmaceutical services industry . The ideal candidate should possess solid knowledge of the Drugs and Cosmetics Act & Rules, Medical Devices Rules, Magic Remedies Act & Rules , along with expertise in regulatory compliance, medication safety, quality assurance, and pharmaceutical operational processes.

Catalogue Compliance

Ensure drug catalogue accuracy, including Salt–Brand–SKU mapping .

Classify medicines into OTC, Prescription, Restricted, Banned, and Cold Chain categories.

Ensure all catalogue updates comply with applicable regulatory requirements.

Prescription Management

Collaborate with pharmacist teams for high-risk medicine reviews.

Doctor & Clinical Consultation Compliance

Maintain compliance standards for doctor credential verification.





Establish clinical governance for prescription-linked workflows.

Dispensing & Fulfilment Compliance

Ensure compliant pick-pack-dispatch processes.

Oversee batch, expiry, cold-chain, and warehouse compliance.

Quality & Risk Management

Manage Corrective and Preventive Actions (CAPA) and continuous quality improvement initiatives.

Conduct internal audits and maintain inspection readiness.

Develop compliance dashboards and monitor key quality KPIs.

Candidates with 4–7 years of experience in one or more of the following industries:

Pharmaceutical Manufacturing

Pharmaceutical Companies

Regulatory Compliance

Pharmaceutical Quality Assurance

Warehouse Compliance

LASA (Look-Alike Sound-Alike) Management

Audit & Inspection Readiness

Quality Management Systems (QMS)

📌 Regulatory Affairs (Mumbai)
🏢 Truemeds
📍 Mumbai

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