Global Regulatory Affairs Manager – Strategy & HA Liaison

Chiesi Farmaceutici S.p.A.; Cary (NC); Hybrid; USD 150,000 - 230,000; Part time

Job summary

Chiesi Farmaceutici S.p.A. in Cary, NC is seeking a senior Regulatory Affairs professional to act as a core member of the Global Regulatory Team and partner with the Global Regulatory Lead to shape and execute global regulatory strategies.

You will support HA interactions, align product profiles across development stages, and drive NDA/BLA submissions in a timely manner. This hybrid role requires 5+ years in R&D with 3+ years in Regulatory Affairs, strong communication and project management,

Qualifications

• BS/BA in Chemistry, Pharmacy, or Biologic Science. Graduate degree preferred.
• 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, of drug regulations, regulatory procedures and drug development guidance; Regulatory Affairs Certification highly preferred
• Able to manage complex tasks and prioritize accordingly
• Effective in verbal and written communication
• Strategic thinking and decision making
• Able to work in a matrix and in multicultural teams
• Good knowledge of regulatory tools for tracking and archiving
• Good knowledge of the basic Office programs
• Ability to prepare PowerPoint presentations
• Ability to search and retrieve information from the worldwide web
• Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines
• Proficient in MS Office (Word, Excel, Project), Adobe and ISI Toolbox.

Responsibilities

• Serve as core member of Global Regulatory Team and partner to Global Regulatory Lead to define and execute global regulatory strategy.
• Ensure target product profiles align across development and lifecycle management.
• Possibly lead regional regulatory activities and serve as a contact with Health Authorities.
• Contribute to development of global HA interaction strategy with GRT members.
• Develop HA engagement plans and author, lead, and moderate meetings.
• Communicate with HAs, affiliates, and IMDD partners, tracking in systems.
• Lead regulatory subteams to deliver NDA/BLA/MAA filings on time and develop core dossiers.
• Ensure submission timelines align with program objectives.
• Contribute to content and reviews of regulated documents.
• Support GMP, GCP, and GPV inspections; assist in compliance activities.
• Provide project/submission status updates to GRT members.
• Support updates to Affiliates and interactions with IMDD and partners.
• Contribute to sustainability goals and demonstrate value for patients, customers, employees, community and planet.

Skills

Regulatory knowledge

Strategic thinking

Cross-functional collaboration

Verbal & written communication

Project management

MS Office Proficiency

Education

BS/BA in Chemistry, Pharmacy, or Biologic Science

Graduate degree preferred

Tools

ISI Toolbox

MS Project

Adobe

PowerPoint

Job description

Chiesi Farmaceutici S.p.A. in Cary, NC is seeking a senior Regulatory Affairs professional to act as a core member of the Global Regulatory Team and partner with the Global Regulatory Lead to shape and execute global regulatory strategies.

You will support HA interactions, align product profiles across development stages, and drive NDA/BLA submissions in a timely manner. This hybrid role requires 5+ years in R&D with 3+ years in Regulatory Affairs, strong communication and project management,