JOB TITLE:  Senior Director, Regulatory Affairs

DEPARTMENT: Regulatory Affairs

Location:  South San Francisco, CA (Onsite / Hybrid)

TYPE: Full-Time

HI-Bio, Inc. is a clinical-stage biotechnology company based in South San Francisco, California. Our shared purpose is to transform the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. Our pipeline is strong and built through both in-licensing and discovery. HI-Bio's team is made up of industry experts from science and clinical drug development. We are on a path to building a leading immunology company. To accomplish this, we are seeking top talent to join us on our journey.

Reporting to the Senior Vice President, Regulatory Affairs, the Senior Director, Regulatory Affairs is responsible for the development and implementation of our global regulatory strategy. This role will provide regulatory leadership at a program level and 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. 

KEY RESPONSIBILITIES:

• Leads the design and implementation of regulatory strategies for assigned development programs, providing strategic guidance and leadership to project teams on all regulatory matters
• Collaborate with team members, management, and consultants to define regulatory pathways at a global level 
• Oversee the preparation, submission, and management of regulatory submissions (e.g., INDs, CTAs, BLAs, MAAs), ensuring compliance with applicable regulations and guidelines
• Establish and maintain effective relationships with the FDA and other relevant regulatory agencies; serve as the primary point of contact for assigned programs
• Plan, implement, and lead effective interactions with regulatory authorities, including FDA, EMA, and other global health authorities, to facilitate successful regulatory submissions and approvals
• Proactively identify regulatory risks and develop mitigation strategies 
• Ensure compliance with relevant regulatory requirements, company policies, and industry standards, maintaining the highest standards of ethical conduct and integrity
• Contribute to the project team by developing or overseeing the overall content and timing of regulatory filings, consistent with applicable regulations, guidelines, and standards
• Remain current with evolving regulatory requirements, guidelines, and competitive landscape to inform regulatory strategy and decision-making
• Support the regulatory aspects of new or ongoing clinical trials, including during study start up, study conduct, and study completion
• Author documents for regulatory filings as needed; work with other team members to define the outline and content of documents for regulatory filings
• Represent the company externally in regulatory matters, including participation in industry forums, conferences, and regulatory agency meetings
• Manage or direct the management of timelines to ensure regulatory filings occur on time
• Identify and assess regulatory risks and risks to timelines for assigned projects or programs
• Monitor and review regulatory agency communications such as changes to regulations and guidelines, and summarize these for team members, as appropriate
• Ensure internal regulatory compliance by developing effective departmental procedures, including development and review of SOPs
• Work to influence external regulatory environment through active participation in conferences and industry/agency regulatory meetings, committees and trade associations
• Champion our culture through living our values and mentoring junior colleagues 

EDUCATION AND QUALIFICATIONS:

• Advanced degree in life sciences, pharmacy, or related field; PhD or PharmD preferred; experience in immunology is a plus
• 15+ years of industry regulatory experience with roles of increasing responsibility
• 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

HI-BIO RECRUITING:
HI-Bio, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all employees.