AM / DM - Regulatory Affairs (Non Orals) - Vadodara

Alembic Pharmaceuticals; Vadodara; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Alembic Pharmaceuticals, Vadodara, is seeking an Assistant Manager / Deputy Manager - Regulatory Affairs to manage US market submissions for non-oral dosage forms, including sterile products. You will drive post-approval activities, lifecycle management, and liaise with cross-functional teams to ensure US FDA compliance.

The role requires strong hands-on experience with US regulatory requirements, eCTD publishing, and regulatory software tools, with a focus on PAS, CBE submissions, and annual

Qualifications

• 7–12 years of regulatory affairs experience in pharma.
• Hands-on US market regulatory experience.
• Post-Approval/Life Cycle Management expertise.
• Experience with sterile/injectable/ophthalmic/non-oral dosage forms.
• Experience with PAS, CBE-30, CBE-0, AR filings.
• Working knowledge of USFDA CFRs.

Responsibilities

• Support US regulatory submissions and lifecycle management.
• Coordinate with cross-functional teams to ensure compliance.
• Maintain electronic submission processes and systems.

Skills

US Market RA

Lifecycle Management

Sterile dosage forms

PAS and CBE filings

USFDA CFR knowledge

Electronic submissions

eCTD publishing

Regulatory software

Education

B.Pharm / M.Pharm / M.Sc. or equivalent

Job description

Assistant Manager / Deputy Manager - Regulatory Affairs (US Market, Non-Oral)

Location: Vadodara, Gujarat

Job Summary

We are seeking a highly motivated Regulatory Affairs professional to support US regulatory activities for Non-Oral dosage forms, particularly Sterile products. The incumbent will be responsible for post-approval regulatory submissions, lifecycle management, and coordination with cross-functional teams to ensure compliance with USFDA requirements.

Required Experience

• 7 to 12 years of Regulatory Affairs experience in the pharmaceutical industry.
• Hands-on experience in US Market Regulatory Affairs.
• Strong experience in Post-Approval/Life Cycle Management activities.
• Experience with Sterile/Injectable/Ophthalmic/Non-Oral dosage forms is mandatory.
• Experience in preparation and submission of PAS, CBE-30, CBE-0, Annual Reports, and other post-approval filings.
• Working knowledge of USFDA regulations, CFR requirements, and guidance documents.

Technical Skills

• Experience in Electronic Submission Management.
• Knowledge of eCTD publishing and submission processes.
• Hands-on experience with regulatory software/tools.

Qualification

B.Pharm / M.Pharm / M.Sc. or equivalent qualification.