Assistant Manager, Regulatory Affairs

Growth For Impact; Gujarat; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Growth For Impact in Gujarat is seeking a Regulatory Affairs specialist to prepare, review, coordinate, and finalize CMC modules for oral solids, liquids, injectables, and other dosage forms, while supporting due-diligence projects for US, EU, and Canada markets.

You will manage pre-approval submissions, prepare status updates and white papers for decision-making, assess change controls, and help develop regulatory tools and checklists to support department needs.

Qualifications

• Knowledge of relevant regulatory guidelines and updates.
• Ability to perform under changing priorities, deadlines, and regulatory expectations.
• Strong technical writing, presentation, training, and effective communication/coordination skills.
• Positive learning orientation to quickly adapt to Amneal systems, regulatory affairs tools, and processes.

Responsibilities

• Prepare, scientifically review, coordinate, and finalize ANDA/NDA CMC modules for oral solid, oral liquid, injectable, and other dosage forms.
• Work on due‑diligence projects for US, EU, and Canada markets in accordance with business agreements.
• Manage pre‑approval portfolio, including original submissions, deficiency responses, final approval requests, and other submissions.
• Prepare project status updates, discussion slides, and white papers for escalation and decision‑making at various project stages.
• Assess change controls and provide necessary regulatory comments and approvals.
• Support development and updating of regulatory tools, checklists, and databases as required by the department.

Skills

Regulatory guidelines

Adaptability

Technical writing

Communication

Learning mindset

Job description

ROLE

• – Prepare, scientifically review, coordinate, and finalize ANDA/NDA CMC modules for oral solid, oral liquid, injectable, and other dosage forms.


• – Work on due‑diligence projects for US, EU, and Canada markets in accordance with business agreements.


• – Manage pre‑approval portfolio, including original submissions, deficiency responses, final approval requests, and other submissions.


• – Prepare project status updates, discussion slides, and white papers for escalation and decision‑making at various project stages.


• – Assess change controls and provide necessary regulatory comments and approvals.


• – Support development and updating of regulatory tools, checklists, and databases as required by the department.

REQUIREMENTS

• – Knowledge of relevant regulatory guidelines and updates.


• – Ability to perform under changing priorities, deadlines, and regulatory expectations.


• – Strong technical writing, presentation, training, and effective communication/coordination skills.


• – Positive learning orientation to quickly adapt to Amneal systems, regulatory affairs tools, and processes.