Global Regulatory Affairs Manager – Hybrid/Remote

NCBioImpact; Cary (NC); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Top-class benefits

Healthcare programs

Work-life balance

Relocation support

Flexible working

Remote work options

Tax assistance

Job summary

Chiesi USA in Cary, NC is seeking a senior Regulatory Affairs professional to lead global regulatory strategy and interactions with health authorities to ensure timely filings and lifecycle management.

You will collaborate with the Global Regulatory Lead and Global Regulatory Team to develop engagement plans, prepare submissions, and monitor program timelines across regions, while maintaining high standards of quality and compliance.

Qualifications

• Bachelor-level degree in a scientific field; graduate degree preferred.
• Minimum of 5 years in research and development with 3+ years in Regulatory Affairs.
• Knowledge of drug development process, regulations, and guidance; Regulatory Affairs Certification preferred.
• Able to manage complex tasks and prioritize effectively.

Responsibilities

• Serve as regional/local regulatory lead or contact with Health Authorities.
• Contribute to global HA engagement strategy with GRT members.
• Develop health authority engagement plans and lead preparation meetings.
• Ensure timely regulatory submissions and align dossiers with program goals.
• Support GMP, GCP, and GPV inspections and regulatory inspections.
• Provide updates on submission status to GRT and affiliates.

Skills

Regulatory Affairs

Global HA engagement

Regulatory strategy

Verbal and written communication

Strategic thinking

Education

BS/BA in Chemistry, Pharmacy, or Biologic Science

Graduate degree preferred

Tools

Regulatory tracking tools

MS Office (Word, Excel, Project)

Adobe

ISI Toolbox

Job description

Chiesi USA in Cary, NC is seeking a senior Regulatory Affairs professional to lead global regulatory strategy and interactions with health authorities to ensure timely filings and lifecycle management.

You will collaborate with the Global Regulatory Lead and Global Regulatory Team to develop engagement plans, prepare submissions, and monitor program timelines across regions, while maintaining high standards of quality and compliance.