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  • 2 - 7 Years
  • Posted : above 1 month

Job Description:

Regulatory Affairs Officer/executive-2-7yrs-bphrama/mpharma

2 - 7 Years

Aurangabad



The person will be responsible for the activities at site related to registration and regulatory affairs in USA, Europe, Australia, Brazil, ROW - including South Africa, etc
To provide all the necessary support to corporate RA for regulatory submissions related to formulations for all countries
To share the regulatory deficiencies with concerned departments and provide related response and documents to corporate RA for further action
To ensure regulatory compliance by providing required documentation for the submission of amendments, supplements/variations and timely Annual updates
To review and approve all master documents and review of executed documents (like Specifications, Test Methods, Batch Production Records, Stability Protocols and Reports, etc) prior to submission
Evaluation of post approval changes for impact assessment and regulatory filings If required, consult corporate RA and co-ordinate with other departments to understand the regulatory submission strategies

Salary INR 3,00,000 - 5,50,000 PA

IndustryPharma / Biotech / Clinical Research

Functional AreaProduction, Manufacturing, Maintenance

Role CategorySenior Management

RoleHead/VP/GM-Regulatory Affairs

Keyskills

Regulatory Affairs South Africa Regulatory Compliance RA

Desired Candidate Profile

Please refer to the Job description above
Education-

UGBPharma - Pharmacy

PGMPharma - Pharmacy

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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