Regulatory Affairs - US -Executive Shilpa Medicare

2.0 - 7.0 years

2 - 7 Lacs

hyderabad

Work from Office

Role & responsibilities CMC and Labelling: Preparation of ANDAs in eCTD format for various type of formulations Review of the technical documents such as Specifications, BMR, MFC, Able to work on All type of CTD section write-ups Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS) Through knowledge on ICH guidances Should able to handle Module -I related activities Able to review Drug substance DMF and should prepare a due diligence eCTD Related activities: Complete knowledge on eCTD related publishing activities Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC’s etc., should adhere to FDA published latest gui...

Posted 3 weeks ago

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Associate - CSCC & RM (Regulatory Operations) M/s Gi Human Resources And Services

1.0 - 5.0 years

5 - 12 Lacs

mumbai

Hybrid

REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS. MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liai...

Posted 1 month ago

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Officer-Regulatory Affairs - with Leading Pharma CDMO in USA Best Fit Recruitment Rider

0.0 - 2.0 years

1 - 4 Lacs

ahmedabad

Work from Office

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Posted 2 months ago

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Executive - Regulatory Affairs with USA based Pharma Company Best Fit Recruitment Rider

1.0 - 6.0 years

5 - 8 Lacs

ahmedabad

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Posted 2 months ago

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Executive - Regulatory Affairs with USA based Pharma Company Best Fit Recruitment Riders

2.0 - 7.0 years

5 - 8 Lacs

Ahmedabad

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Posted 5 months ago

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