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Drug Regulatory Affairs

Najafgarh
Full-Time
Junior: 2 to 4 years
30K - 40K (Per Month)
Posted on Jul 02 2024

Not Accepting Applications

About the Job

Skills

Regulatory Affairs
DRA
Strong communication skills
Validation (Drug Manufacture)
cdsco
sugam
Pharmacovigilance
Device Master File

Position Name : Drug Regulatory Executive(DRA Executive)Only Female Candidates needed.

Candidates Having The Central Drugs Standard Control Organization(CDSCO) experience and similar with these organizations can apply.

compiling comprehensive dossiers, and reviewing technical documents such as AMV, MFR, PVPR,

BMR, STS, STP, COA, stability reports, protocols, and API documents. Seeking a challenging role to leverage this experience and drive

regulatory excellence.

Form 8, Form 12, Form 16, Form 19, Form 40 & Form 42

 Form CT-04, CT-16 & CT-18

 Form MD-14, MD-16, MD-22, MD-24, MD-26 & MD-28

 Preparation of Informed Consent Documents

 Preparation & Submission of Post approved and various

applications on SUGAM portal

To prepare data about a new product for doctors and other healthcare professionals for harmless and effective practice of medicine and maintain records, and reports of post-marketing surveillance of the new product. It also helps to prepare the leaflets and advertising material for existing as well as new drugs.

Documentation for Italy, Brazil,Belgium,USA.

Required Expertise: Stability Data , Process Validation, Pharmacovigilance,

Job Types: Full-time, Regular / Permanent

Job Type: Full-time

Pay: ₹30,000.00 - ₹35,000.00 per month

About the company

Bhargava Consulting Group (formerly known as Bhargava HR Solution) was established in 2017 with a policy of "Sourcing & Placing of Top Talent" The Bhargava HR Solution explored in 2023 for the Human Resource services, and Regulatory & documentations service to the Medical Devices, IVD Medical Devices, Diagnostics Laboratories & Pharmaceuticals industries with the name of Bhargava Consulting Group ...Show More

Industry

Management Consulting

Company Size

11-50 Employees

Headquarter

Noida , Uttar Pradesh

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