Senior Executive – Regulatory Affairs (US ANDA | Sterile Injectables | CMC Strategy)
Location: Ahmedabad, Gujarat, India
Department: Regulatory Affairs
Job Type: Full-Time
Application Deadline: 15 March 2026
Job ID: 7189
Qualification Required: M.Pharm
Company: Amneal Pharmaceuticals
Role Overview
Amneal Pharmaceuticals is seeking a Senior Executive – Regulatory Affairs to manage U.S. FDA submissions for sterile dosage forms including Injectables, Ophthalmics, Otics, and IV Bags. This role focuses on ANDA compilation, amendment submissions, deficiency management, regulatory strategy development, and lifecycle maintenance for sterile products developed using aseptic and/or terminal sterilization processes.
The position requires strong expertise in US FDA regulations, CMC documentation, API DMF review, change control evaluation, and health authority correspondence. The selected candidate will play a critical role in minimizing regulatory deficiencies, ensuring timely approvals, and accelerating product launches in the United States market.
This opportunity is ideal for regulatory professionals with hands-on experience in sterile ANDA filings and FDA communications.
Key Responsibilities
ANDA Submission & Regulatory Filing
Compile, review, and submit ANDA dossiers and amendments to the US FDA.
Ensure submissions meet FDA requirements and avoid Refuse-to-Receive (RTR) or major deficiencies.
Prepare and submit post-approval supplements including CBE, CBE-30, and PAS.
Develop regulatory strategies to optimize approval timelines.
Sterile Dosage Expertise
Manage ANDA submissions for sterile dosage forms including Injectables, Ophthalmic, Otic, and IV Bags.
Ensure regulatory compliance for products developed via aseptic sterilization and/or terminal sterilization techniques.
Regulatory Strategy & Lifecycle Management
Evaluate change controls and determine appropriate regulatory filing categories.
Assess compositions for IIG compliance and proportionality criteria to avoid filing issues.
Prepare and finalize Controlled Correspondence and Pre-Submission meeting packages (Pre-ANDA, Pre-IND, Pre-NDA).
Manage product lifecycle activities including amendments, annual reports, and post-approval changes.
FDA Deficiency & Query Management
Perform detailed gap assessments upon receipt of FDA deficiency letters.
Develop strategic response plans in collaboration with internal stakeholders.
Compile and submit deficiency responses within regulatory timelines.
Cross-Functional Collaboration
Work closely with R&D, Quality, Manufacturing, and Bio-Execution teams from product initiation through stability phases.
Review API DMFs and coordinate with procurement and DMF holders to ensure compliance.
Support regulatory documentation during development and commercialization phases.
Compliance & Documentation Management
Maintain systematic archiving of submissions and regulatory documents.
Ensure alignment with ICH guidelines, FDA regulations, and 21 CFR requirements.
Stay updated on regulatory changes affecting sterile generics.
Required Experience
5 to 8 years of experience in US Regulatory Affairs within the pharmaceutical industry.
Proven hands-on experience in sterile ANDA submissions (Injectables/Ophthalmics/Otics/IV Bags).
Strong knowledge of aseptic and terminal sterilization regulatory requirements.
Experience handling FDA deficiency letters and health authority correspondences.
Prior exposure to INDs, NDAs, and Controlled Correspondence is preferred.
Experience reviewing API DMFs and managing CMC documentation.
Educational Qualification
Master of Pharmacy (M.Pharm) required.
Core Competencies
Advanced knowledge of US FDA regulations, ICH guidelines, and 21 CFR.
Expertise in Regulatory Strategy Development and Risk Mitigation.
Strong background in CMC documentation and Product Lifecycle Management.
Advanced skills in Health Authority Query Response and Change Control Assessment.
Excellent technical writing and verbal communication skills.
Strong analytical, organizational, and time-management capabilities.
Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Professional.
Why Join Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company committed to expanding access to affordable medicines. The organization fosters innovation, compliance excellence, and operational efficiency while maintaining a strong focus on regulatory integrity and product quality.
Amneal promotes diversity, inclusion, and equal opportunity, providing a collaborative work environment that supports professional growth and global regulatory exposure.
Equal Opportunity Statement
Amneal Pharmaceuticals is an equal opportunity employer and does not discriminate based on caste, religion, gender, disability, or any legally protected status.
Apply now through ThePharmaDaily.com to advance your career in US Regulatory Affairs, sterile ANDA strategy, and global pharmaceutical compliance.
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