Regulatory Affairs Manager

Were hiring a hands-on Manager Regulatory Affairs to own USFDA submissions, ANDA lifecycle management, and facility/product compliance for external application products manufactured at our facility. Youll report to the Regulatory Head/Director and work closely with Quality, Manufacturing, and R&D teams to navigate FDA requirements and bring products to market efficiently.

This is an execution-driven role with direct ownership of USFDA outcomesnot a consulting or coordination role.

What Youll Be Responsible For

USFDA Submissions & CMC Execution

• Prepare, compile, review, validate, and submit ANDA dossiers for external application products (creams, ointments, gels, lotions, and similar dosage forms)
• Manage CMC sections for topical/external dosage forms, including formulation rationale, excipient justification, specifications, and stability data
• Own labeling strategies and regulatory narratives aligned with USFDA expectations
• Handle FDA Refuse to File (RTF), Deficiency Response Letters (DRL), and Complete Response Letters (CRL)
• Own submission timelines and deliverables through approval

Regulatory Queries & Post-Approval Lifecycle

• Respond to FDA Information Requests (IR), ECDs, administrative queries, and deficiency letters
• Manage approved product lifecycle for external application products, including:
• Annual Reports
• PADER submissions
• CBE-0, CBE-30, and PAS filings
• Draft and manage Controlled Correspondence with USFDA
• Maintain inspection- and audit-ready regulatory documentation

Facility & Product Registration

• Execute and maintain compliance under GDUFA, OMUFA, and MoCRA
• Manage Drug Establishment Registration and NDC drug listing (OTC and prescription topical products)
• Handle Labeler Code, FEI, and DUNS registrations
• Oversee 3PL registrations and WDD renewals
• Coordinate with QA during USFDA inspections (remote or on-site), where applicable

Quality & Documentation Management

• Work with SPL and eCTD software for submission compilation and publishing
• Review and validate technical documentation from internal teams and CMC partners
• Coordinate regulatory impact assessments for formulation, manufacturing, and labeling changes
• Stay current with FDA guidance relevant to topical/external dosage forms impacting assigned products

What Were Looking For

Required Experience

• 8+ years of hands-on USFDA Regulatory Affairs experience within a pharmaceutical manufacturing organization
• Proven experience preparing and submitting ANDA applications for topical/external dosage forms
• Strong track record handling CMC and labeling deficiencies
• Demonstrated ownership of post-approval lifecycle submissions
• Comfort working independently with eCTD and SPL systems

Education

• M.Pharm (Pharmaceutics / Regulatory Affairs preferred)
• B.Pharm (minimum)
• D.Pharm acceptable with 7+ years of relevant USFDA RA experience

Mindset & Approach

• Detail-oriented with zero tolerance for compliance gaps
• Comfortable owning dossiers end-to-end without handholding
• Calm, structured problem-solver under FDA timelines
• Strong written communicator precision matters in submissions

Technical Skills (Non-Negotiable)

• ANDA preparation and submission for external application products
• FDA deficiency handling (IR, DRL, ECD, CRL, RTF)
• GDUFA, OMUFA, MoCRA compliance
• NDC listing, Drug Establishment Registration, Labeler Code management
• Post-approval filings: Annual Reports, CBE-0, CBE-30, PADER, PAS
• eCTD and SPL software proficiency
• Working knowledge of 21 CFR Part 314, 21 CFR Parts 210/211, and FDA guidance for topical products
• Ability to estimate regulatory timelines and submission effort based on scope and pathway
• Awareness of pharmacovigilance interfaces (e.g., MedWatch) for coordination purposes

Who This Role Is Ideal For

Youve spent 8+ years in USFDA regulatory affairs at a pharmaceutical manufacturer working on topical or other external application products. Youve written ANDAs, responded to FDA deficiencies, and managed approved products through their lifecycle. You understand eCTD, respect FDA timelines, and dont panic when a CRL arrives.

Youre looking for technical ownership, stability, and the satisfaction of bringing compliant products to market not client management or consulting chaos.

What This Role Is NOT

• Not a Director- or Head-level strategic role
• Not a consultancy or CRO position
• Not a pharmacovigilance or audit-only role
• Not suitable for early-career professionals without USFDA ANDA exposure
• Not a role that outsources core regulatory thinking

Why Join Us

• Direct ownership of USFDA approvals and lifecycle management
• Deep specialization in regulated topical/external dosage forms
• Manufacturing-led environment focused on systems, not firefighting
• Clear growth path within a regulated pharmaceutical organization