Executive / Sr. Executive – Post Approval Injectable

RXinsider LTD.; Ahmedabad District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

RXinsider LTD. is seeking an Executive/Sr. Executive in Regulatory Affairs (Post-Approval Injectables) in Ahmedabad.

The role focuses on post-approval submissions, lifecycle management, and ensuring compliance with USFDA and ICH guidelines for sterile injectable products. The candidate will lead regulatory submissions, manage annual reports and post-approval activities, and collaborate with Manufacturing, QA, R&D, and Supply Chain to ensure timely document collection and submission readiness.

Qualifications

• Experience in post-approval regulatory affairs for injectable products.
• Familiarity with USFDA post-approval regulations and ICH guidelines.
• Strong CTD drafting and document review skills.
• Ability to manage multiple regulatory submissions and timelines.

Responsibilities

• Prepare and support post-approval regulatory submissions for injectables.
• Manage annual reports, CBE-0, CBE-30, PAS submissions per USFDA requirements.
• Maintain regulatory records, submission trackers, and lifecycle documents.
• Coordinate with cross-functional teams for timely collection of submission documents.
• Stay updated on USFDA regulations, ICH guidelines, and industry best practices.

Skills

Regulatory filings

Post-approval submissions

Annual Reports & CBE submissions

Regulatory compliance & intelligence

Documentation & record control

Cross-functional collaboration

Analytical thinking

Effective communication

Data governance & compliance

Education

B.Pharm

M.Pharm (preferred)

Tools

CTD drafting

Job description

We're Hiring | Executive / Sr. Executive – Regulatory Affairs (Post Approval Injectables)

Location: Ahmedabad

Qualification: B.Pharm (Mandatory), M.Pharm (Preferred)

Experience: 5-8 Years

About the Role

We are looking for a Regulatory Affairs professional with strong experience in Post-Approval Regulatory Affairs for Injectable Products. The role involves managing regulatory submissions, lifecycle maintenance activities, and ensuring compliance with USFDA and ICH requirements for sterile and complex injectable products.

Key Responsibilities

Regulatory Submission Management

1. Prepare, review, compile, and support post-approval regulatory submissions for injectable products.
2. Manage Annual Reports, CBE-0, CBE-30, PAS, and other post-approval submissions as per USFDA requirements.
3. Ensure timely preparation and submission of regulatory documents in line with approved regulatory strategies and business timelines.
4. Perform preliminary review of submission packages to ensure completeness, accuracy, and regulatory compliance.

Regulatory Compliance & Strategy

1. Evaluate change cases and assess regulatory filing requirements based on ICH guidelines and USFDA post-approval regulations.
2. Support regulatory decision-making related to manufacturing, process, formulation, packaging, and quality-related changes.
3. Monitor regulatory requirements and provide recommendations to ensure ongoing product compliance.

Documentation & Reporting

1. Draft Annual Reports with required supporting information as per USFDA guidance.
2. Maintain regulatory records, submission trackers, and product lifecycle documentation.
3. Ensure all regulatory information is accurately maintained and archived as per internal procedures.

Cross-Functional Collaboration

1. Coordinate with Manufacturing, Quality Assurance, Quality Control, R&D, Supply Chain, and other cross-functional teams for timely collection of submission documents.
2. Ensure effective communication and follow-up to prevent delays in regulatory submissions.
3. Participate in discussions related to change controls, deviations, investigations, and post-approval commitments.

Product & Regulatory Knowledge

1. Support products involving sterile dosage forms and complex injectable formulations.
2. Maintain awareness of commercial marketing status notification requirements, content expectations, and submission timelines.
3. Stay updated with evolving USFDA regulations, ICH guidelines, and industry best practices related to post-approval regulatory affairs.

Required Skills

1. Regulatory Filings & Documentation
2. Post-Approval Submission Management
3. Annual Reports, PAS, CBE-0 & CBE-30 Submissions
4. Regulatory Compliance & Regulatory Intelligence
5. Documentation & Record Control
6. Cross-Functional Collaboration
7. Analytical Thinking & Problem Solving
8. Effective Communication & Stakeholder Management
9. Data Governance & Compliance

Preferred Candidate Profile

1. Hands-on experience in Post-Approval Regulatory Affairs for Injectable Products.
2. Good understanding of ANDA lifecycle management and post-approval submission requirements.
3. Familiarity with sterile and complex injectable products and related regulatory expectations.
4. Strong CTD drafting and document review skills.
5. Ability to work in a fast-paced environment while managing multiple priorities and strict regulatory timelines.

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