Global Regulatory Affairs Lead, Nephrology - Remote

Overview

Biogen’s West Coast Hub is focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies. We are seeking a Global Regulatory Affairs Lead to spearhead global regulatory strategies for our immunology portfolio.

In Short

• Lead regulatory strategy design and implementation for development programs.
• Collaborate globally to define regulatory pathways.
• Manage regulatory submissions and maintain compliance.
• Establish relationships with regulatory agencies.
• Engage with global health authorities for successful submissions.
• Identify and mitigate regulatory risks.
• Stay updated on regulatory changes.
• Support regulatory aspects of clinical trials.
• Author regulatory documents.
• Direct timelines for regulatory filings.

Requirements

• Advanced degree in life sciences or related field.
• 8+ years’ experience in the pharmaceutical industry.
• Comprehensive regulatory knowledge across various regions.
• Proven track record of strategic planning and execution.
• Exceptional leadership and collaboration skills.
• Creative analytical thinker and problem solver.
• Up-to-date with regulatory guidelines.
• Superb oral and written communication abilities.

Benefits

• Full range of benefits including medical, dental, and life insurance.
• 401K participation and matching contributions.
• Vacation and end-of-year shutdown.
• Participation in LTI grants and other incentive programs.