Global Regulatory Affairs Manager

Chiesi Group • Cary, NC

4d • Hybrid

About The Position

The Global Regulatory Affairs Manager serves as a core member of the Global Regulatory Team (GRT) and a strategic partner to the Global Regulatory Lead (GRL). The role helps define and execute global regulatory strategy in support of business objectives and supports strategy execution for assigned regions, ensuring Target Product Profiles remain aligned throughout product development and lifecycle management. The position is hybrid and based in Cary, North Carolina.

Requirements

• Bachelor of Science or Bachelor of Arts 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 accordingly.
• Effective verbal and written communication skills.
• Strategic thinking and decision-making skills.
• Ability to work in a matrix and in multicultural teams.
• Knowledge of regulatory tools for tracking and archiving.
• Knowledge of basic Office programs.
• Ability to prepare PowerPoint presentations and 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.
• Regulatory Affairs Certification.

Responsibilities

• Serve as a regional or local regulatory lead and point of contact internally and with Health Authorities, as applicable.
• Contribute to global Health Authority interaction strategy in collaboration with GRT 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 in delivering NDA, BLA, MAA, extension, variation, and renewal filings on time, and develop core global dossiers with Project Managers and GRT members.
• Ensure regulatory submission timelines align with program-level and company objectives.
• Contribute to the content of and review regulated documents.
• Support operational and compliance activities for assigned deliverables.
• Support Health Authority GMP, GCP, and GPV inspections.
• Provide GRT members with updates on project and submission status.
• Support the GRL with updates to affiliates and interactions with IMDD and partners.
• Contribute to sustainability goals that benefit 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.
• Development resources and training.

What This Job Offers

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