Hybrid Global Regulatory Strategy Lead

Chiesi USA, Inc.; Cary (NC); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Healthcare programs

Relocation support

Flexible working arrangements

Remote work options

Tax assistance for foreign colleagues

Job summary

Chiesi USA, Inc. is seeking an experienced Regulatory Affairs professional to define and execute global regulatory strategies.

You will serve as a trusted partner to the Global Regulatory Lead, coordinating with Health Authorities and cross-functional teams to advance product development and lifecycle management in a complex, multinational environment. The role requires 5+ years in R&D with Regulatory Affairs experience, RAC preferred, and strong communication skills.

Qualifications

• BS/BA in Chemistry, Pharmacy, or Biologic Science; Graduate degree preferred.
• At least 5 years R&D including 3+ years direct Regulatory Affairs experience.
• Knowledge of drug development process and regulations; RAC highly preferred.
• Able to manage complex tasks and prioritize.
• Strong verbal and written communication.
• Strategic thinking and decision-making.
• Able to work in a matrix and in multicultural teams.
• Proficient in MS Office, Adobe, and ISI Toolbox.
• Ability to prepare PowerPoint presentations.
• Ability to search and retrieve information from the worldwide web.

Responsibilities

• Serve as regional/local regulatory lead and point of contact with Health Authorities.
• Develop global HA interaction strategy with GRT members.
• Create Health Authority engagement plans for assigned products.
• Ensure timely NDA/BLA/MAA filings with Project Managers and GRT members.
• Ensure regulatory submission timelines align with program objectives.
• Contribute to content and reviews of regulated documents.
• Support operational and compliance activities for deliverables.
• Support GMP, GCP, and GPV inspections from health authorities.
• Provide updates on project and submissions status to GRT members.
• Assist GRL on updates to Affiliates and interactions with IMDD and partners.
• Contribute to sustainability goals.

Skills

Regulatory strategy

Communication

Project management

Cross-functional collaboration

MS Office

PowerPoint

Regulatory tools

Education

BS/BA in Chemistry/Pharmacy/Biologic Science

Graduate degree preferred

Regulatory Affairs Certification (RAC)

Tools

ISI Toolbox

Adobe

Job description

Chiesi USA, Inc. is seeking an experienced Regulatory Affairs professional to define and execute global regulatory strategies.

You will serve as a trusted partner to the Global Regulatory Lead, coordinating with Health Authorities and cross-functional teams to advance product development and lifecycle management in a complex, multinational environment. The role requires 5+ years in R&D with Regulatory Affairs experience, RAC preferred, and strong communication skills.