Director, Regulatory Affairs – CMC/Biologics

ICON plc

Regulatory CMC Director guiding biologics submissions for ICON, a global clinical research organization. Advising clients on drug development, manufacturing, approvals, and post-approval maintenance.

Posted 8/14/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory CMC strategy and documentation for biologics and pharmaceuticals, with a strong focus on compliance and project management. Capable of providing strategic regulatory advice and managing client submissions throughout the drug development lifecycle.

Highest-signal resume keywords

Regulatory CMC ExperienceBiologics DevelopmentIND/NDA/BLA Submission ManagementRegulatory Strategy DevelopmentCertification in Regulatory Affairs (RAC)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory CMC DocumentationDrug DevelopmentBiologics ManufacturingTechnical DevelopmentSubmission ApprovalsProject ManagementBudget ManagementRegulatory ComplianceNegotiation SkillsMonitoring Regulatory Requirements

Soft Skills

Strategic AdviceCommunication SkillsClient ManagementTeam CollaborationPeople Management

Certifications & Qualifications

Certification in Regulatory Affairs (RAC)

Industry Keywords

PharmaceuticalsBiologicsSmall and Large MoleculesBiosimilarsCGTADCsVaccinesPeptidesRadiopharmaceuticalsUS FDA Regulations

About the role

Key responsibilities & impact

Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues and clients
Manage preparation of regulatory CMC submission documents for INDs, NDAs, BLAs, NDSs, ANDAs and post-approval supplements
Facilitate submission approvals and amendments through communications and negotiations with clients, government agencies and project teams
Anticipate and develop initial or alternative regulatory strategies
Provide clients with strategic advice based on regulatory experience and area of expertise
Monitor new regulatory requirements and share key findings
Lead or participate in quotations for projects crossing multiple service areas
Manage projects within budget and prepare change orders as needed
Support US FDA drug listing, drug establishment registrations and lot distribution reports
Serve as US Agent for client submissions and interface with local agency and sponsor
Support client submissions from preclinical through post-approval activities

Requirements

What you’ll need

Bachelor’s degree in a relevant discipline, preferably life sciences or another healthcare field
Relevant pharmaceutical or biologics regulatory experience in a global environment
Experience in technical development, testing and manufacturing of a wide range of dosage forms
Demonstrable experience in a regulatory CMC role or delivering regulatory CMC strategy and documentation during drug development or product maintenance
Experience with small and large molecules, including biologics, biosimilars, CGT, ADCs, vaccines, peptides and radiopharmaceuticals
CMC experience
Experience supporting business development activities and people management is an asset
Certification in regulatory affairs (RAC) or post-secondary institution is beneficial
Legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary
Performance related incentives
Medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Professional development opportunities
Reasonable accommodations during the recruitment process