Director of International Regulatory Affairs (Clinical)

Nationally recognized biopharmaceutical company, innovating medicines for the treatment of cancer and autoimmune diseases is seeking a Director of International Regulatory Affairs for a Direct Hire/ Hybrid Remote position on their team.

Responsibilities:

• As local regulatory lead, represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in regulatory affairs to provide guidance to colleagues for preparation of regulatory documents
• Serve as an internal expert in international Regulatory Affairs by providing strategic and operational guidance to management and project teams for the international registration of new products or new indications, especially for the US, EU and Australia, etc. including:

o Provide interpretation regarding regulations and advice on interactions with agencies (FDA, EU…) and their guidance and requirements. Monitor and anticipate changes in regulatory and access environments that might impact company portfolio programs and provide timely advice to the management and project team.
o Identify and assess regulatory risks, mitigations, and contingencies.
o Support China product RA lead or indication RA lead to prepare and review meeting requests, briefing documents, and responsible for the submission and follow up the review and responses to requests from regulatory authorities.

• Work with China product RA lead or indication RA lead to plan, prepare, and review submissions to regulatory agencies (FDA, EU…) to support RA submission approval. Ensure all documents and communications with regulatory agencies are timely, accurate, complete, verifiable, and in compliance with agencies' requirements.
• Responsible for organizing FDA communication meetings to ensure meeting quality.
• Responsible for managing CRO depending on project assignment.
• Responsible for the preparation, review, and submission of ODD documents in the United States and Europe.
• Provide related local regulatory consulting works as per request by the China product RA lead or indication RA lead.
• Liaison with Health Authorities as needed
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs

Benefits:
401(k)
401(k) matching
Dental insurance
Flexible schedule
Health insurance
Health savings account
Paid time off
Professional development assistance
Referral program

EXPERIENCE

• Advanced degree (PhD, etc.) in life science discipline, biological science, clinical research or any other healthcare field and 10+ years of experience with regulatory affairs pharmaceutical or biotechnology firm.
• Fluent in Mandarin and English.
• Working knowledge of FDA regulatory requirements for IND and BLA.
• Extensive understanding of eCTD modules, regulations, clinical research principles and drug development processes.
• Ability to write regulatory modules in eCTD system, and to manage overall project scope and timelines using appropriate skills.
• Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners or CROs.
• Experience from IND through to BLA, across all disciplines (nonclinical, clinical, CMC)
• Knowledge and understanding of autoimmune and oncology disease biology and translational research is a plus.
• Strong written and verbal communication skills.
• Dynamic individual with ability to lead, organize and motivate team members.
• Ability to work effectively both independently and in a team environment.
• Strong organizational and planning skills.
• Excellent interpersonal and professional skills.
• Excellent time management skills with the ability to prioritize responsibilities and multitask.
• Self-motivated and detail oriented.
• Proficient in Microsoft Office and able to learn appropriate software.