Senior Director, Regulatory Affairs

South San Francisco, CA, United States

JOB TITLE: Senior Director, Regulatory Affairs

DEPARTMENT: Regulatory Affairs

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.

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