Senior Executive Dishman Carbogen Amcis Ltd

5.0 - 9.0 years

0 Lacs

gujarat

On-site

Role Overview: As a Senior Executive at Dishman Carbogen Amcis Limited in Bavla, Gujarat, you will be responsible for preparing DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines. You will also handle responses to queries from regulatory agencies and customers, prepare Applicants Part of ASMF based on customer requirements, and manage renewals and revisions for CEPs / annual reports for USDMFs / ASMF variations. Additionally, you will stay updated on global regulatory requirements, evaluate change control applications for regulatory implications, and provide regulatory input for analytical method validation reports and stability protocols. Key Responsibilities: - Prepare DMF / AS...

Posted 10 hours ago

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Executive - Regulatory Affairs (API Business) RPG Life Sciences

8.0 - 10.0 years

6 - 8 Lacs

navi mumbai

Work from Office

Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures. Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc. Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licen...

Posted 1 month ago

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Regulatory Affairs - API ( Jr. Executive/Executive/Sr. Executive ) Biophore

2.0 - 7.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Posted 3 months ago

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Executive Regulatory Affairs API Industry Hikal Limited ,Unit1

3.0 - 5.0 years

1 - 5 Lacs

Bengaluru

Work from Office

Role & responsibilities We are hiring for the role of Executive - Regulatory Affairs department (API Industry ) Preferred candidate profile Candidate with 3 to 6 years experience in the Regulatory Affairs (API Industry) can apply for the job . Please drop relevant cvs to ramya_n@hikal.com

Posted 3 months ago

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API Regulatory Affairs Executive / Officer Harman Finochem

5.0 - 10.0 years

5 - 12 Lacs

aurangabad

Work from Office

Hi, We have opening for the position of API regulatory affairs department for API Manufacturing industry. Role & responsibilities 1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries 2. Submission of DMF amendments and variation filings to implement the post approval changes 3. Evaluation of change controls and perform regulatory assessment based on submitted DMF 4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D and review of documents received for registration purpose. 5. To Maintain regulatory database by following best regulatory practices 6. To prepare action plan for De...

Posted Date not available

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