Senior Executive – Regulatory Affairs (Back Office | Injectables)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Function: Regulatory Affairs – US FDA (CMC)
Industry: Pharmaceuticals
Experience Level: Senior Executive
Job Overview
A leading pharmaceutical organization is seeking a highly experienced Senior Executive – Regulatory Affairs (Back Office) to manage US FDA ANDA submissions and lifecycle activities for sterile injectable dosage forms. The role is responsible for ensuring high-quality regulatory submissions, minimizing deficiencies, and supporting timely product approvals through strong compliance with US FDA, ICH, and 21 CFR regulations.
This position requires deep expertise in sterile products manufactured using aseptic and/or terminal sterilization techniques, along with hands-on experience in post-approval change management and FDA correspondence.
Key Responsibilities
ANDA Submissions & Lifecycle Management
Compile, prepare, review, and submit ANDA dossiers and amendments to the US FDA with a focus on avoiding major deficiencies and achieving expedited approvals.
Maintain complete visibility of regulatory activities across assigned projects, ensuring timelines, quality standards, and performance targets are consistently met.
Ensure timely submission of all assigned regulatory projects.
Sterile Product Regulatory Expertise
Manage regulatory submissions for Injectables, Ophthalmic, Otic, and IV Bag dosage forms.
Apply regulatory knowledge across aseptic sterilization and terminal sterilization manufacturing processes.
Evaluate final formulations against Inactive Ingredient Guide (IIG) limits and proportionality criteria to prevent Acceptable for Filing (AFF) issues.
Post-Approval Submissions & Change Control
Review change controls and determine appropriate filing strategies with minimal supervision.
Prepare and submit post-approval supplements including CBE, CBE-30, and PAS.
Proactively escalate critical regulatory or project-related issues to senior stakeholders for resolution.
Cross-Functional Collaboration
Work closely with R&D, Quality, Manufacturing, Analytical, Regulatory Operations, and Supply Chain teams during product initiation, development, bio studies, stability initiation, and post-approval stages.
Ensure timely availability of complete documentation to support regulatory submissions.
FDA Correspondence & Deficiency Management
Prepare and finalize 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 develop response strategies in alignment with senior management.
Support regulatory teleconferences aligned with US time-zone requirements.
API DMF Review & Compliance
Perform thorough reviews of API Drug Master Files (DMFs) in line with US FDA expectations.
Share regulatory review comments with procurement teams and DMF holders and follow up to ensure timely compliance.
Documentation, Compliance & Knowledge Management
Maintain systematic archiving of all regulatory submissions and correspondence.
Ensure ongoing compliance with ICH guidelines, FDA regulations, and 21 CFR requirements.
Stay current with evolving regulatory requirements impacting sterile injectable products.
Support administrative activities to ensure smooth departmental operations.
Required Qualifications
Bachelor of Pharmacy (B. Pharm) or Master of Pharmacy (M. Pharm) from a recognized institution.
Experience Requirements
5–7 years of hands-on experience in Regulatory Affairs (CMC) with a strong focus on US FDA submissions.
Proven expertise in sterile dosage forms including Injectables, Ophthalmic, Otic, and IV Bags.
Direct experience with aseptic and/or terminal sterilization processes is mandatory.
Prior exposure to ANDAs, INDs, NDAs, and FDA correspondence is required.
Key Skills & Competencies
Strong knowledge of US FDA regulations, ICH guidelines, and 21 CFR.
Excellent technical writing, documentation, and communication skills.
High attention to detail with the ability to manage multiple submissions under tight timelines.
Strong analytical and problem-solving capabilities.
Ability to work independently as well as collaboratively in cross-functional teams.
Effective stakeholder communication across domestic and international teams.
Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Acrobat Professional.
Work Flexibility
Flexibility to align working hours with US regulatory team schedules for teleconferences and submission coordination.
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 accordance with business requirements.
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