Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)

Added
37 minutes ago
Type
Full time
Salary
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Related skills

fda regulatory strategy health authorities qdp grpt

πŸ“‹ Description

  • Develop and implement US & Canada regulatory strategy (RSTP) for assigned products.
  • Ensure regulatory strategies align with GRPT and evolving regulatory needs.
  • Gather data to support filings, responses, and registration maintenance.
  • Interface with FDA for meetings and briefing packages.
  • Advise internal teams on Regulatory/FDA issues and cross-functional impacts.
  • Prepare and review regulatory submissions for US/Canada and respond to Health Authorities.

🎯 Requirements

  • Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related).
  • 6 years Regulatory, R&D, or industry experience.
  • Experience in complex, matrix environments and government interfaces.
  • Strong negotiation and communication skills.
  • Proven ability to implement US/Canada regulatory strategies.

🎁 Benefits

  • AbbVie benefits package including PTO and health coverage.
  • Eligibility for long-term incentive programs.
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