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Executive, Regulatory Affairs at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

ANDA Submission, Post-approval Procedures, ICH Guidelines, USFDA Guidelines, API DMF Review, CTD Modules Drafting, Regulatory Compliance, Annual Report Drafting, CBE 0/CBE 30/PAS Filing, Controlled Correspondence, Cross Functional Coordination, Regulatory Submission Planning

Industry

Pharmaceutical Manufacturing

Description
Description: * Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. * API DMF and DMF Change Notification review with respect to USFDA regulatory requirement. * Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form /  topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. * Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling  * Drafting of the Annual Report with required submission data as per USFDA guidance. * Preliminary review of entire submission package. * Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects. * Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. * Coordination with Cross Functional teams for the documents availability as per regulatory submission plan. * Ensure the no delay in drafting and compiling the regulatory submission. * Maintain regulatory information as per allocated task. * Having good Regulatory CTD modules drafting & preliminary review skills. Additional Responsibilities:
Responsibilities
Manage ANDA submission activities and post-approval procedures in compliance with ICH and USFDA guidelines. Responsible for drafting annual reports, reviewing change cases, and coordinating with cross-functional teams for regulatory documentation.