Senior Executive – Regulatory Affairs (US FDA Submissions)
Location: India (Multi-location)
Employment Type: Full-Time
Function: Regulatory Affairs – US Markets
Industry: Pharmaceuticals
Experience Level: Senior Executive
Job Overview
A leading global pharmaceutical organization is seeking a Senior Executive – Regulatory Affairs to support US FDA regulatory submissions and post-approval activities. The role involves hands-on responsibility for ANDA lifecycle management, regulatory documentation, API DMF reviews, and coordination with cross-functional teams to ensure timely, compliant submissions across multiple dosage forms.
This position is ideal for professionals with strong knowledge of ICH guidelines, US FDA regulations, and CTD dossier preparation, and experience supporting complex regulatory submissions.
Key Responsibilities
ANDA Submissions & Post-Approval Activities
Support ANDA submission activities, including compilation, review, and lifecycle maintenance.
Manage post-approval submissions in line with US FDA guidance, including Annual Reports, CBE-0, CBE-30, and PAS filings.
Draft and compile Annual Reports with complete and accurate submission data.
Regulatory Documentation & Review
Conduct preliminary reviews of complete submission packages to ensure regulatory compliance and submission readiness.
Prepare and review CTD Modules, ensuring alignment with US FDA and ICH quality requirements.
Draft controlled correspondence and briefing packages to the FDA for assigned regulatory cases.
API DMF & Change Control Review
Review API Drug Master Files (DMFs) in compliance with US FDA regulatory expectations.
Assess change control cases in line with ICH quality guidelines and post-approval change requirements.
Support regulatory impact assessments for formulation, manufacturing, and process changes.
Dosage Form Expertise
Provide regulatory support across multiple dosage forms, including:
Solid Oral Dosage Forms
Sterile Products
Complex Dosage Forms
Topical and Inhalation Products
Demonstrate working knowledge of manufacturing processes and key regulatory considerations for each dosage form.
Cross-Functional Coordination
Coordinate with cross-functional teams such as R&D, Quality, Manufacturing, and Regulatory Operations to ensure timely document availability.
Ensure adherence to regulatory submission timelines with no delays in drafting or compilation.
Maintain regulatory records and submission trackers as per assigned responsibilities.
Regulatory Intelligence & Compliance
Stay current with US FDA guidance related to commercial marketing status notifications, including content and submission timelines.
Ensure regulatory information is accurately maintained and readily available for audits and inspections.
Educational Qualifications
Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences from a recognized institution.
Experience Requirements
Minimum 3–6 years of relevant experience in US Regulatory Affairs within the pharmaceutical industry.
Proven experience with ANDA submissions, post-approval changes, and CTD dossier preparation.
Exposure to API DMF reviews and regulatory change control assessments is required.
Key Skills & Competencies
Strong knowledge of US FDA regulations and ICH guidelines.
Hands-on experience in CTD module drafting and regulatory dossier review.
Excellent technical writing, documentation, and communication skills.
Strong coordination and stakeholder management abilities.
High attention to detail with the ability to manage multiple submissions simultaneously.
Ability to work independently in a deadline-driven regulatory environment.
Work Environment & Values
The organization promotes a workplace culture rooted in diversity, inclusion, and ethical business practices. Employees are encouraged to collaborate across functions while maintaining the highest standards of regulatory compliance and professional integrity.
Equal Opportunity Statement
The employer is an equal opportunity organization and does not discriminate based on caste, religion, gender, disability, or any other 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 as required by business needs.
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Brazil | Sao paulo |Attica :
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