Regulatory Affairs Director

3 days ago

South San Francisco, California, United States Annexon Bioscience Full time
Job Summary

We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Annexon Biosciences. As a key member of our regulatory team, you will be responsible for providing global regulatory leadership and direction to support the development, registration, and life-cycle management of our innovative programs.

Key Responsibilities
  • Develop and implement regulatory strategies and plans to meet company objectives
  • Collaborate with cross-functional teams to develop, coordinate, and implement regulatory submissions for global CTAs
  • Provide strategic regulatory direction on programs to support the global regulatory plan, development plans, and clinical study designs
  • Liaise with FDA, EMA, and other regulatory agencies as needed
  • Oversee the preparation and submission of assigned sections of filings to regulatory authorities
  • Lead and manage FDA/EMA meetings, including leading briefing documents and meeting minutes
  • Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics
Requirements
  • PhD/PharmD with 12+ years' experience in Regulatory Affairs or BS/MS/MSN with 14+ years' experience
  • Experience in a successful leadership role in managing late-stage clinical candidate drugs
  • Experience in working directly with the FDA and EMA
  • Superior scientific writing skills for developing regulatory documents
  • Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement, and patient care
What We Offer
  • A stimulating and rewarding workplace with flexible work schedules, remote opportunities, and the ability to achieve a work-life balance
  • A competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package
  • A diverse and inclusive work environment that values diversity, equity, inclusion, and belonging

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