Global Regulatory Affairs Lead, HI-Bio

Job Description

HI-Bio, Inc., a Biogen company, is seeking a Global Regulatory Affairs Lead to develop and implement global regulatory strategy for programs in our immunology portfolio. This position requires in depth experience leading regulatory strategy and an innate ability to adapt and move quickly in a startup environment. Our ideal candidate will have experience in the immunology space and expertise in global regulatory filings.

Reporting to Head of Regulatory Affairs, HI-Bio, your responsibilities will include:

• Leading the design and implementation of regulatory strategies for assigned development programs, providing strategic guidance and leadership to project teams on all regulatory matters
• Collaborating with team members, management, and consultants to define regulatory pathways at a global level
• Overseeing the preparation, submission, and management of regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs), ensuring compliance with applicable regulations and guidelines
• Establishing and maintaining effective relationships with the FDA and other relevant regulatory agencies; serve as the primary point of contact for assigned programs
• Planning, implementing, and leading effective interactions with regulatory authorities, including FDA, EMA, and other global health authorities, to facilitate successful regulatory submissions and approvals
• Proactively identifying regulatory risks and develop mitigation strategies
• Ensuring compliance with relevant regulatory requirements, company policies, and industry standards, maintaining the highest standards of ethical conduct and integrity
• Contributing to the project team by developing or overseeing the overall content and timing of regulatory filings, consistent with applicable regulations, guidelines, and standards
• Remaining current with evolving regulatory requirements, guidelines, and competitive landscape to inform regulatory strategy and decision-making
• Supporting the regulatory aspects of new or ongoing clinical trials, including during study start up, study conduct, and study completion
• Authoring documents for regulatory filings as needed; work with other team members to define the outline and content of documents for regulatory filings
• Representing the company externally in regulatory matters, including participation in industry forums, conferences, and regulatory agency meetings
• Managing or directing the management of timelines to ensure regulatory filings occur on time
• Identifying and assessing regulatory risks and risks to timelines for assigned projects or programs
• Monitoring and reviewing regulatory agency communications such as changes to regulations and guidelines, and summarize these for team members, as appropriate
• Ensuring internal regulatory compliance by developing effective departmental procedures, including development and review of SOPs
• Working to influence external regulatory environment through active participation in conferences and industry/agency regulatory meetings, committees and trade associations
• Championing our culture through living our values and mentoring junior colleagues

Qualifications

• Advanced degree (MS, PhD or PharmD) in life sciences, pharmacy, or related field with 10+ years of industry experience of increasing responsibility. In lieu of advanced degree, 15+ years of experience required. Experience in immunology is a plus
• Broad regulatory experience across multiple therapeutic areas, geographical regions (US, Canada, EU, Japan) and therapeutic modalities
• Experience with all aspects of the regulatory process including strategy (agency interactions, application planning) and operations (meeting request, background packages, IND through NDA/BLA submissions)
• Strong leadership and communication skills, with the ability to influence and collaborate effectively across functions and levels of the organization
• Energetic, creative, analytical problem solver who acts independently yet communicates broadly so that appropriate business decisions can be made
• Strategic thinker with the ability to anticipate and mitigate regulatory risks
• Knowledge of current and changing regulatory landscape and guidelines for BLAs and other therapeutic programs
• Excellent oral and written communication skills
• Ability to collaborate and influence across all levels of the organization
• Demonstrated ability to thrive in a fast-paced, entrepreneurial environment

The ideal candidate is local to California and can commute in a hybrid nature to our San Francisco office. For the right candidate we will consider a fully remote role.

Additional Information

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are