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Job id : 163782

Executive / Sr. Executive: Regulatory and Business Continuity

Executive / Sr. Executive: Regulatory and Business Continuity

  Vadodara
   SunPharma        Vadodara
  17 hours ago      19 Applied

JOB ID:163782

Job details

Job Type

  Returnee Program

Functional Area

Pharmacist/Bio-Technologist

Industry

Pharma/Biotech/Clinical Research

Education

Not Specified

Experience Required

  4 - 7 Yrs

Key Skills Required

  ectd compilation, verification and submission

Other Skills Required

 

Job Description

· Education : M. Pharm

· Experience : 4-7 years

1) Review all data and documents related to product registrations for various health authorities.

2) Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

3) Prepare responses to deficiency letters received from various agencies.

4) Maintain life-cycle / post approval changes for drug product registration dossiers.

5) Provide regulatory support to cross functional departments.

6) eCTD compilation, verification and submission through electronic gateway

About Company

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.