Regulatory Affairs Manager

18 ore fa

Milano, Lombardia, Italia Option One Life Science Consulting Sagl A tempo pieno

Regulatory Affairs Manager | Clinical Development (CTA/IND) | EU/US/RoW

ABOUT / INFO

Regulatory Affairs professional with years of experience in the pharmaceutical industry, supporting global clinical development programs across EU, US and RoW. Strong track record in managing clinical trial applications and maintenance activities (CTA/IND), coordinating complex submission packages, and ensuring compliance with international regulatory requirements (ICH/GCP).

Experienced in regulatory strategy and execution, including formal meeting with major Regulatory Agencies. Experienced in the submission of ODD, PIP, NDA/BLA and MAA. Used to working in cross-functional environments, partnering closely with Clinical Operations, CMC, Pharmacovigilance, and external CROs to deliver high-quality dossiers within tight timelines.

Key strengths include regulatory intelligence, critical thinking, structured problem-solving, and the ability to translate complex regulatory expectations into actionable project plans. Passionate about scientific innovation and contributing to projects addressing orphan drugs and unmet medical needs.

Areas of expertise:

  • Global CTA/IND/IMPD submissions and maintenance
  • MAA/NDA/BLA submissions
  • EU/US/RoW regulatory requirements for medicines licenses
  • Authority liaison and response management
  • DSUR / Annual Safety Reporting support and PV interface
  • Cross-functional coordination
  • High-quality document preparation and submission planning

Keywords / Skills

  • Regulatory Affairs (Clinical Development)
  • CTA / IND / IMPD submissions
  • MAA / NDA / BLA
  • EU CTR / Clinical Trial Regulation
  • Competent Authorities interactions
  • Regulatory strategy
  • Substantial amendments
  • DSUR / ASR
  • SUSAR reporting (oversight/coordination)
  • ICH / GCP compliance
  • Clinical trial documentation (Protocol, IB, ICF, responses)
  • Regulatory intelligence / guidelines monitoring
  • ODD / UMN therapeutic areas

Target roles

  • Regulatory Affairs R&D Manager

Areas:

  • Pharma / Biotech

Are you interested?

Send your application or contact us directly for a confidential conversation.

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