Regulatory Affairs CMC Author – Remote (US, Blue Bell – ICON)
Company: ICON plc
Job Type: Full-Time
Location: Remote (United States – Blue Bell, PA affiliation)
Experience Required: 3–5 Years in Regulatory Affairs (CMC Focus)
About ICON plc
ICON plc is a global healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies across the product development lifecycle. ICON partners with leading life sciences organizations to deliver regulatory, clinical, and commercialization solutions that accelerate patient access to innovative therapies.
Job Overview
ICON plc is seeking a Regulatory Affairs CMC Author to support the Global Regulatory Affairs CMC & Device function within a Plasma-Derived Therapies Business Unit. This role is responsible for authoring and managing high-quality Chemistry, Manufacturing, and Controls (CMC) regulatory submissions across global markets.
The position operates within a highly matrixed, global product team environment and collaborates closely with Regulatory CMC Strategists, Manufacturing, Quality SMEs, Regulatory Operations, and R&D stakeholders to ensure compliant, timely, and globally aligned CMC submissions.
This opportunity is ideal for professionals with hands-on experience in regulatory submission authoring, global CMC dossier management, and lifecycle regulatory strategy within pharmaceutical or biotechnology organizations.
Key Responsibilities
CMC Regulatory Submission Authoring
Manage routine CMC authoring and submission activities for assigned products or portfolios.
Prepare high-quality, compliant global regulatory submission documents.
Ensure consistency and alignment with global CMC dossier templates and ICH guidelines.
Identify country-specific regulatory submission requirements.
Dossier and Template Management
Maintain and update regulatory CMC dossier templates aligned with current ICH and regional requirements.
Manage core source file systems supporting global plasma CMC submission activities.
Ensure global CMC documentation consistency in structure, format, and content.
Cross-Functional Collaboration
Partner with Global Regulatory Affairs CMC Strategists to define submission scope and strategy.
Collaborate with Global Manufacturing and Quality SMEs for technical accuracy.
Act as liaison with Regulatory Operations and Publishing teams.
Coordinate document review sessions and consolidate feedback for final approval.
Regulatory Intelligence and Process Optimization
Stay current with global submission standards, formats, and evolving regulatory requirements.
Support development of efficient submission authoring processes and trackers.
Contribute to continuous improvement initiatives within regulatory documentation workflows.
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific field (advanced degree preferred).
Minimum 3–5 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience in CMC regulatory authoring and submission management.
Strong knowledge of global regulatory requirements including ICH guidelines for clinical development, product registration, and lifecycle management.
Proven ability to manage regulatory submissions and interact effectively with regulatory agencies.
Strong attention to detail with excellent written communication skills.
Ability to work effectively in a global, matrixed team environment.
Preferred Skills
Experience in plasma-derived therapies or biologics.
Familiarity with global dossier preparation (eCTD format).
Experience supporting regulatory lifecycle activities including variations and renewals.
Compensation and Benefits
ICON offers competitive compensation along with comprehensive benefits tailored to each country. Benefits may include:
Health insurance coverage
Retirement planning options
Paid annual leave
Life assurance
Employee Assistance Programs
Flexible voluntary benefits
ICON is committed to fostering a diverse, inclusive, and discrimination-free workplace. All qualified applicants will receive equal consideration for employment.
Who Should Apply?
This role is ideal for:
Regulatory Affairs CMC Specialists
CMC Regulatory Writers
Regulatory Submission Managers
Global Regulatory Affairs Professionals
Biologics and Plasma-Derived Product Regulatory Experts
If you are an experienced Regulatory Affairs professional with expertise in CMC documentation and global submission strategy, this remote opportunity offers strong exposure to global regulatory operations within a leading CRO environment.
For more global regulatory affairs, clinical research, pharmacovigilance, and life sciences job opportunities, visit ThePharmaDaily.com.
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