Amneal Pharmaceuticals is hiring Executive – Regulatory Affairs in Ahmedabad, Gujarat

Amneal Pharmaceuticals is inviting applications for the position of Executive – Regulatory Affairs at its Ahmedabad, Gujarat location. Candidates with 5–8 years of experience in Regulatory Affairs, particularly in ANDA submissions and post-approval activities, are encouraged to apply.

This is an excellent opportunity for experienced Regulatory Affairs professionals looking to advance their careers with one of the leading global pharmaceutical companies.

Job Details

Company: Amneal Pharmaceuticals
Position: Executive – Regulatory Affairs
Location: Ahmedabad, Gujarat, India
Department: Regulatory Affairs
Experience: 5–8 Years
Qualification: B.Pharm (Required), M.Pharm (Preferred)

Job Responsibilities

• Handle ANDA submission activities and post-approval regulatory procedures.
• Prepare and review submissions in accordance with ICH and USFDA guidelines.
• Review change control cases based on ICH Quality and USFDA post-approval guidance.
• Prepare and compile Annual Reports, CBE-0, CBE-30, and Prior Approval Supplement (PAS) submissions.
• Perform preliminary review of regulatory submission packages.
• Support commercial marketing status notification submissions as per FDA requirements.
• Coordinate with cross-functional teams to collect submission documents within timelines.
• Ensure timely drafting, compilation, and submission of regulatory documents.
• Maintain regulatory information and documentation.
• Draft and review CTD modules with high accuracy.
• Work on sterile dosage forms and complex injectable regulatory submissions.

Required Skills

• Strong knowledge of ANDA submissions.
• Good understanding of ICH and USFDA regulatory requirements.
• Experience in post-approval regulatory submissions.
• Knowledge of sterile and complex injectable dosage forms.
• Regulatory documentation and CTD drafting skills.
• Good communication and coordination abilities.
• Ability to manage multiple regulatory projects within deadlines.

Educational Qualification

• Required: B.Pharm
• Preferred: M.Pharm

Experience Required

• 5–8 years of relevant experience in Regulatory Affairs.

Job Location

Ahmedabad, Gujarat, India

Why Join Amneal Pharmaceuticals?

• Opportunity to work with a globally recognized pharmaceutical organization.
• Exposure to international regulatory submissions.
• Career growth in Regulatory Affairs.
• Collaborative and innovation-driven work environment.

How to Apply

Interested and eligible candidates can apply through the official Amneal Pharmaceuticals Careers Portal and submit their updated resume for the Executive – Regulatory Affairs position.

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