Global Regulatory Affairs Manager

Chiesi Farmaceutici • Cary, NC

3d • Hybrid

About The Position

This position serves as a core member of the Global Regulatory Team (GRT) and a strategic partner to the Global Regulatory Lead (GRL), helping define and execute global regulatory strategy to deliver business objectives. The role supports execution of global regulatory strategy for assigned regions and ensures Target Product Profiles (TPPs) remain aligned throughout development and lifecycle management.

The position may serve as a regional or local regulatory lead and point of contact for internal stakeholders and Health Authorities. It contributes to Health Authority interaction strategy, develops engagement plans, and oversees accurate communication and tracking for assigned products. The role leads regulatory subteams and coordinates global dossiers and regulatory filings in alignment with program and company objectives. It also supports regulated document review, operational and compliance activities, inspections, and status updates to the GRT, affiliates, partners, and IMDD colleagues.

The role is based in Cary, North Carolina, in a hybrid work arrangement. The employee is expected to contribute to the company’s sustainability goals and shared-value mindset.

Requirements

• Bachelor’s degree in Chemistry, Pharmacy, or Biological Science.
• At least 5 years of research and development experience, including 3 or more years of direct Regulatory Affairs experience.
• Knowledge of the drug development process, drug regulations, regulatory procedures, and drug development guidance.
• Ability to manage complex tasks and prioritize appropriately.
• Effective verbal and written communication skills.
• Strategic thinking and decision-making skills.
• Ability to work in a matrix environment and in multicultural teams.
• Good knowledge of regulatory tools for tracking and archiving.
• Good knowledge of basic Office programs and ability to prepare PowerPoint presentations.
• Ability to search for and retrieve information from the worldwide web.
• Ability to manage multiple tasks and multifunctional resources concurrently, maintain attention to detail, and respond to changing priorities and aggressive deadlines.
• Proficiency in MS Office (Word, Excel, and Project), Adobe, and ISI Toolbox.

Nice To Haves

• Graduate degree preferred.
• Regulatory Affairs Certification highly preferred.

Responsibilities

• Serve as a core member of the Global Regulatory Team and strategic partner to the Global Regulatory Lead in defining and executing global regulatory strategy.
• Support global regulatory strategy execution for assigned regions and maintain alignment of Target Product Profiles throughout development and lifecycle management.
• Serve as a regional or local regulatory lead and point of contact internally and with Health Authorities, as needed.
• Contribute to global Health Authority interaction strategy with Global Regulatory Team members.
• Develop Health Authority engagement and interaction plans for assigned products, including authoring, leading, and moderating preparation meetings.
• Ensure complete and accurate communications and interactions with Health Authorities, affiliates, and IMDD partners, including tracking in relevant systems.
• Lead regulatory subteams to deliver NDA, BLA, MAA, extension, variation, and renewal filings on time.
• Develop core global dossiers with Project Managers and Global Regulatory Team members.
• Ensure regulatory submission timelines align with program-level and company objectives.
• Contribute to the content and review of regulated documents.
• Support operational and compliance activities for assigned deliverables.
• Support Health Authority GMP, GCP, and GPV inspections.
• Provide Global Regulatory Team members with updates on project and submission status.
• Support the Global Regulatory Lead with updates to affiliates and interactions with IMDD and partners.
• Contribute to sustainability goals by demonstrating a shared-value mindset focused on patients, customers, employees, the community, and the planet.

Benefits

• Comprehensive healthcare programs.
• Work-life balance initiatives.
• Relocation support.
• Competitive salary package with performance bonuses and benefits benchmarked against the external market.
• Flexible working arrangements and remote work options.
• Tax assistance services for foreign colleagues.
• Resources and training to support employee development.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager