Regulatory Affairs CMC Author – Remote | Blue Bell, PA, United States
Job ID: JR143557
Location: Blue Bell, Pennsylvania, United States (Remote)
Employment Type: Full-Time
Company: ICON plc
About the Company
ICON plc is a leading global contract research organization (CRO) providing healthcare intelligence and clinical development services to pharmaceutical, biotechnology, and medical device companies. Through strategic partnerships with global sponsors, ICON supports regulatory, clinical, and commercialization programs across all phases of drug development.
Position Overview
ICON plc is hiring a Regulatory Affairs CMC Author to support global Chemistry, Manufacturing, and Controls (CMC) regulatory activities within the Plasma-Derived Therapies Business Unit in collaboration with Takeda Pharmaceutical Company.
This remote role is based in Blue Bell, PA, and focuses on preparing, authoring, and managing high-quality global CMC regulatory submissions across clinical development, product registration, and lifecycle management. The position requires cross-functional collaboration within a highly matrixed global regulatory environment.
Experience Required
Minimum 3–5 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry, with hands-on CMC submission experience.
Key Responsibilities
Author and manage routine CMC regulatory submission documents for assigned products or portfolios.
Prepare high-quality, compliant global regulatory dossiers aligned with ICH and regional health authority requirements.
Maintain and update CMC dossier templates according to current regulatory standards.
Manage core source file systems supporting global plasma CMC submission activities.
Monitor evolving global regulatory requirements, submission formats, and standards.
Collaborate with Global Regulatory Affairs CMC Strategists, Global Manufacturing teams, and Global Quality subject matter experts.
Liaise with regulatory operations teams, including publishing groups, to ensure accurate and timely submission assembly.
Coordinate document review sessions, consolidate feedback, and prepare documents for final approval.
Identify country-specific regulatory requirements and ensure alignment within global submissions.
Support the development of efficient CMC authoring procedures and regulatory tracking systems.
Qualifications
Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
3–5 years of regulatory affairs experience with strong CMC authoring exposure.
In-depth knowledge of global regulatory guidelines, including ICH standards for clinical development, product registration, and lifecycle management.
Demonstrated experience preparing and managing regulatory submissions to global health authorities.
Strong technical writing, attention to detail, and document management skills.
Excellent communication and collaboration abilities within cross-functional global teams.
Key Skills for SEO Optimization
Regulatory Affairs CMC, CMC Author, Global Regulatory Submissions, ICH Guidelines, Dossier Preparation, eCTD Submissions, Pharmaceutical Regulatory Affairs, Plasma-Derived Therapies, Regulatory Writing, Lifecycle Management.
Compensation & Benefits
ICON offers competitive compensation and comprehensive country-specific benefits designed to support employee well-being and work-life balance, including:
Annual leave entitlements
Health insurance coverage
Retirement and savings plans
Life assurance
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits depending on location
Equal Opportunity Statement
ICON plc is committed to fostering an inclusive, diverse, and accessible workplace. All qualified applicants will receive equal consideration for employment without discrimination based on race, religion, gender, disability, or protected veteran status.
How to Apply
Qualified professionals with regulatory CMC expertise are encouraged to apply through the official ICON careers portal. Candidates who may not meet every qualification are still encouraged to apply for consideration for future opportunities.
For more global Regulatory Affairs and Pharmaceutical industry job updates, visit ThePharmaDaily.com.
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