Regulatory Affairs Manager

Location: Bāola

We’re 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. You’ll 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 outcomes —not a consulting or coordination role.

What You’ll 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 We’re 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 hand holding
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., Med Watch) for coordination purposes

Who This Role Is Ideal For

You’ve spent  8+ years in USFDA regulatory affairs  at a pharmaceutical manufacturer working on  topical or other external application products . You’ve written ANDAs, responded to FDA deficiencies, and managed approved products through their lifecycle. You understand eCTD, respect FDA timelines, and don’t panic when a CRL arrives.

You’re 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