Senior Executive – Regulatory Affairs (Injectables)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Industry: Pharmaceuticals – Regulatory Affairs
Function: US Regulatory Submissions (Injectables)
Experience Level: Senior Executive
Job Overview
A leading global pharmaceutical organization is seeking a highly skilled Senior Executive – Regulatory Affairs (Injectables) to manage and support US FDA regulatory submissions for sterile dosage forms. The role involves end-to-end responsibility for ANDA submissions, amendments, post-approval supplements, and FDA correspondence, with a strong focus on quality, compliance, and accelerated approvals.
This position requires in-depth expertise in sterile injectable products and hands-on experience with aseptic and/or terminal sterilization technologies, ensuring submissions are acceptable for filing and free from major deficiencies.
Key Responsibilities
US FDA Submissions & Regulatory Strategy
Compile, prepare, review, and submit ANDA dossiers and amendments to the US FDA with the objective of minimizing deficiencies and achieving timely approvals.
Develop and execute regulatory strategies to ensure submissions meet FDA filing and review expectations without Refuse-to-Receive (RTR) issues.
Prepare and submit post-approval supplements including CBE, CBE-30, and PAS.
Evaluate change controls and determine appropriate filing strategies with minimal supervision.
Sterile Product Expertise
Handle regulatory submissions for sterile dosage forms, including Injectables, Ophthalmic, Otic, and IV Bags.
Apply regulatory expertise across aseptic sterilization and terminal sterilization processes.
Review final formulations against Inactive Ingredient Guide (IIG) and proportionality criteria to mitigate filing risks.
Cross-Functional Collaboration
Work closely with R&D, Quality, Manufacturing, Analytical, Regulatory Operations, and Supply Chain teams from product initiation through post-approval.
Ensure timely availability of complete and compliant documentation during R&D, ANDA filing, bio-studies, and stability initiation phases.
Review API DMFs and provide detailed feedback to procurement teams and DMF holders to ensure compliance.
FDA Correspondence & Deficiency Management
Prepare controlled correspondence and pre-submission meeting packages (Pre-ANDA, Pre-IND, Pre-NDA) for FDA interactions.
Perform detailed gap assessments upon receipt of FDA deficiency letters and formulate response strategies in alignment with senior leadership.
Support teleconferences with US regulatory teams and FDA as per global time-zone requirements.
Compliance, Documentation & Knowledge Management
Maintain structured archival of all regulatory submissions and correspondence.
Ensure adherence to ICH guidelines, FDA regulations, and 21 CFR requirements.
Stay current with evolving regulatory policies impacting injectable products and US submissions.
Support administrative and operational activities to ensure smooth department functioning.
Required Qualifications
Master of Pharmacy (M. Pharm) from a recognized institution.
Experience Requirements
Minimum 4–8 years of relevant experience in US Regulatory Affairs, with strong exposure to ANDA submissions for sterile injectable products.
Proven hands-on experience with Injectables/Ophthalmic/Otic/IV Bags under aseptic and/or terminal sterilization processes.
Prior experience handling ANDAs, INDs, NDAs, FDA responses, and regulatory correspondence is mandatory.
Key Skills & Competencies
Advanced knowledge of US FDA regulatory requirements, ICH guidelines, and 21 CFR.
Strong expertise in CMC documentation, regulatory strategy development, and lifecycle management.
Excellent technical writing, verbal communication, and stakeholder coordination skills.
High attention to detail with strong planning, prioritization, and time management abilities.
Ability to work independently in a fast-paced, deadline-driven regulatory environment.
Strong analytical and problem-solving capabilities.
Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Acrobat Professional.
Technical Skill Proficiency
Regulatory Submissions & Dossier Filing – Advanced
Regulatory Guidelines & Compliance – Advanced
Change Control & Regulatory Impact Assessment – Advanced
CMC Documentation & Lifecycle Management – Advanced
FDA Query & Deficiency Response – Advanced
Cross-Functional Communication – Intermediate
Risk Assessment & Mitigation – Intermediate
Work Environment & Flexibility
Role based in Ahmedabad with flexibility to align with US time zones for regulatory discussions and teleconferences.
Interaction with global regulatory professionals and health authorities.
About the Organization
The organization is an equal opportunity employer committed to fostering a diverse, inclusive, and ethical workplace. All employment decisions are made without regard to caste, religion, gender, disability, or any legally protected status.
Disclaimer
This job description outlines the general nature and scope of the role and is not intended to be an exhaustive list of responsibilities or qualifications. The employer reserves the right to modify duties in line with business requirements.
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