Strategic Global Regulatory Affairs Manager -- Hybrid/Remote

Chiesi; Cary (NC); Híbrido; USD 120 000 - 160 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Healthcare programs

Relocation support

Flexible working arrangements

Tax assistance for foreign colleagues

Resumo da oferta

Chiesi Global Rare Diseases is seeking a Regulatory professional to join the Global Regulatory Team in a hybrid Cary, NC role. You will define and execute global regulatory strategies and support regions to ensure alignment of Target Product Profiles across development and lifecycle management.

You will lead interactions with Health Authorities, develop engagement plans, and steer NDA/BLA/MAA filings with cross-functional teams.

Qualificações

• BS/BA in Chemistry, Pharmacy, or Biologic Science; Graduate degree preferred.
• At least 5 years of research and development experience, including 3+ years in Regulatory Affairs.
• Knowledge of drug development process and regulatory guidance; Regulatory Affairs Certification highly preferred.
• Able to manage complex tasks and prioritize; strong written and verbal communication.
• Strategic thinking and decision making; works in a matrix and multicultural teams.
• Proficient in MS Office, Adobe and ISI Toolbox.

Responsabilidades

• May serve as a regional/local regulatory lead with Health Authorities.
• Contributes to global HA interaction strategy with GRT members.
• Develops Health Authority engagement plans, including authoring and leading meetings.
• Tracks communications with HAs, affiliates, and IMDD partners.
• Leads regulatory subteams to deliver NDA/BLA/MAA filings on time.
• Ensures submission timelines align with program objectives.
• Contributes to content and reviews of regulated documents.
• Supports operational and compliance activities for deliverables.
• Supports GMP, GCP, and GPV inspections.
• Provides project/submission status updates to GRT members.
• Supports GRL updates to Affiliates and IMDD interactions.
• Contributes to sustainability goals and patient impact.

Conhecimentos

Regulatory affairs

Drug development

Communication

Strategic thinking

Matrix teamwork

Formação académica

Bachelor degree

Graduate degree preferred

Ferramentas

MS Office

Adobe

ISI Toolbox

PowerPoint

Descrição da oferta de emprego

Chiesi Global Rare Diseases is seeking a Regulatory professional to join the Global Regulatory Team in a hybrid Cary, NC role. You will define and execute global regulatory strategies and support regions to ensure alignment of Target Product Profiles across development and lifecycle management.

You will lead interactions with Health Authorities, develop engagement plans, and steer NDA/BLA/MAA filings with cross-functional teams.