Senior Executive – Regulatory Affairs (Back Office) – Sterile ANDA (USFDA)
Location: Ahmedabad City, Gujarat, India
Employment Type: Full-Time
Experience Required: 5–7 Years
Education: B.Pharm / M.Pharm
Application Deadline: 28 February 2026
Position Overview
A leading pharmaceutical organization is seeking a Senior Executive – Regulatory Affairs (Back Office) to manage sterile ANDA submissions for the US market. The role focuses on injectables, ophthalmic, otic, and IV bag dosage forms, including both aseptic and terminal sterilization processes.
The candidate will oversee the complete ANDA lifecycle, including preparation, review, submission, and post-approval management, ensuring compliance with USFDA, ICH, and 21 CFR regulations. This role involves close collaboration with cross-functional teams to deliver timely and accurate regulatory submissions.
Key Responsibilities
Regulatory Submission Management
Prepare, compile, review, and submit ANDA applications and amendments to USFDA.
Manage post-approval supplements, including CBE, CBE-30, and PAS filings.
Conduct preliminary reviews of submission packages and provide regulatory strategies to avoid filing deficiencies.
Evaluate change controls and determine filing strategies with minimal supervision.
Sterile Product Expertise
Provide regulatory oversight for sterile dosage forms including injectables, ophthalmic, otic, and IV bags.
Apply knowledge of aseptic and terminal sterilization techniques.
Review API DMFs and provide timely feedback to procurement teams and DMF holders.
Evaluate final formulations for IIG compliance and proportional similarity criteria.
USFDA Correspondence & Strategy
Prepare controlled correspondence and pre-submission packages (Pre-ANDA, Pre-IND, Pre-NDA).
Assess deficiency letters from USFDA, perform gap analysis, and recommend response strategies.
Maintain awareness of evolving USFDA, ICH, and 21 CFR guidelines affecting sterile products.
Cross-Functional Collaboration
Coordinate with R&D, Quality, Manufacturing, and Analytical teams to ensure timely availability of documents.
Support US teams, including participation in teleconferences as per US time zones.
Ensure regulatory submissions meet project timelines without delays.
Documentation & Compliance
Archive and maintain regulatory submissions systematically.
Support management in administrative and regulatory functions for smooth departmental operations.
Maintain up-to-date regulatory intelligence relevant to sterile pharmaceutical products.
Required Skills & Competencies
Expertise in ANDA lifecycle management and USFDA regulatory submissions.
Strong technical writing, documentation review, and gap assessment skills.
Working knowledge of ICH guidelines, USFDA regulations, and 21 CFR.
Analytical, problem-solving, and project management abilities.
Organizational, multitasking, and prioritization skills in a fast-paced environment.
Effective collaboration with domestic and international stakeholders.
Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Professional.
Qualifications & Experience
B.Pharm / M.Pharm.
5–7 years of Regulatory Affairs CMC experience with sterile dosage forms.
Experience in injectables, ophthalmic, otic, and IV bags.
Knowledge of both aseptic and terminal sterilization techniques.
Proven ability to manage regulatory submissions and post-approval compliance for USFDA.
Why Join?
This role offers a strategic opportunity to contribute to USFDA sterile ANDA submissions within a global pharmaceutical organization. It provides exposure to complex regulatory processes, cross-functional leadership, and the ability to influence product lifecycle strategy for sterile dosage forms. Candidates will gain expertise in regulatory strategy, compliance, and submission excellence in a fast-paced, high-impact environment.
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