Assistant Manager, Regulatory Affairs

RXinsider LTD.; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

RXinsider LTD. is seeking an experienced Regulatory Affairs professional to lead US FDA submission activities and post-approval procedures. The role requires strong CTD drafting skills and collaboration with cross-functional teams to ensure timely regulatory filings.

The candidate should have 8+ years in regulatory affairs, with B. Pharm mandatory and M. Pharm preferred, and exposure to post-approval guidance and annual reports. This position offers growth in a dynamic pharmaceutical environment.

Qualifications

• Bachelor of Pharmacy is required.
• Masters degree (M. Pharm) preferred.
• 8+ years of regulatory affairs experience.
• Experience with US FDA submissions and CTD modules.

Responsibilities

• Prepare and submit regulatory submissions to USFDA.
• Review and compile Annual Reports and other supplements as required.
• Coordinate with cross-functional teams for document readiness.
• Draft and review CTD modules with accuracy and completeness.
• Ensure timely completion of submissions and maintain regulatory information.

Skills

US FDA guidelines

Regulatory submissions

CTD drafting

Cross-functional coordination

Education

B. Pharm

M. Pharm

Job description

Job Description

• Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
• Ability to 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
• Preparation and submission of controlled correspondence
• Review and compilation of Annual Report with required submission data as per USFDA guidance.
• Review and compilation of entire supplement/amendment submission package.
• Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.
• 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 & review skills.

Education

QUALIFICATIONS

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 8 years or more in 8 - 10 Years