Executive, Regulatory Affairs

RXinsider LTD.; India; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

RXinsider LTD. is seeking a regulatory affairs specialist with expertise in ANDA submissions and post-approval activities. The role involves coordinating with cross-functional teams and ensuring timely regulatory submissions.

The ideal candidate holds a B.Pharm (M.Pharm preferred) and has 5+ years of experience working with ICH quality guidelines and USFDA requirements.

Qualifications

• Candidate must hold a B. Pharm degree; an M. Pharm is preferred.
• Minimum 5 years of experience in regulatory affairs for pharma.
• Experience with ICH, USFDA guidelines and regulatory submissions.

Responsibilities

• Draft annual regulatory submissions and reports as per guidelines.
• Pre-review of entire submission package for accuracy.
• Coordinate with cross-functional teams to gather required documents.
• Ensure timely drafting and compilation of regulatory submissions.
• Maintain regulatory information per assigned tasks.

Skills

Regulatory submissions

ICH guidelines

USFDA guidelines

Quality review

CTD drafting

Education

B.Pharm

M.Pharm

Job description

Description

JOB DESCRIPTION

• Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• Exposure of the Sterile dosage form / complex injectable 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.
• 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 & preliminary review skills.

Education

QUALIFICATIONS

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

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge:

Licenses: