ICON plc

Director, Regulatory Affairs – CMC

ICON plc

full-time

Posted on:

Location Type: Hybrid

Location: Blue Bell • Pennsylvania • United States

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Job Level

Lead

About the role

  • Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice
  • Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements
  • Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
  • Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
  • Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
  • Enthusiastically monitors for new regulatory requirements and shares key findings.
  • Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
  • Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports
  • Serve as US Agent for client submissions and act as interface with local agency and sponsor
  • Support right from preclinical to post approval activities for client submissions.

Requirements

  • Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
  • Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
  • Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. US, EU, Canada).
  • Technical development, testing and manufacturing of wide range of dosage forms
  • Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
  • Experience supporting business development activities and people management an asset.
  • Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords

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

Hard Skills & Tools
regulatory CMCINDsNDAsBLAsNDSsANDAsDrug listing (NDC)Drug establishment RegistrationsLot Distribution Reportstechnical development
Soft Skills
communicationnegotiationstrategic adviceproject managementanticipationleadershippeople management
Certifications
regulatory affairs certification (RAC)