Vice President, Regulatory Affairs

Hinge Bio; Redwood City (CA); Vor Ort; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

Hinge Bio seeks an experienced Vice President of Regulatory Affairs to lead global regulatory strategy and execution for biologics, guiding programs from preclinical stages through IND submission and early clinical development. This senior leader partners with Clinical Development, CMC, Quality, and Executive Leadership to advance immunology and oncology programs.

The VP will represent Hinge Bio with regulatory authorities, shape development pathways, and provide strategic regulatory input to

Qualifikationen

• Deep understanding of FDA regulations, ICH guidelines, and global regulatory requirements.
• Experience leading global regulatory strategy for biologics.
• Experience preparing and leading FDA interactions and regulatory meetings.

Aufgaben

• Develop and execute global regulatory strategies for biologics from preclinical development through clinical proof-of-concept.
• Lead regulatory planning and risk assessment for development programs, ensuring alignment with objectives and timelines.
• Provide strategic guidance on regulatory requirements, expedited pathways, and interactions with health authorities.
• Build and lead a scalable regulatory function appropriate for a growing biotechnology company.
• Lead preparation for FDA meetings (Pre-IND, INTERACT, Type B, End-of-Phase) and develop briefing documents.

Kenntnisse

FDA regulations

ICH guidelines

Global regulatory requirements

CMC knowledge

Strategic thinking

Influence without authority

Communication skills

Project management

Regulatory leadership

Ausbildung

Advanced life sciences degree

PhD, PharmD, MD, or MS strongly preferred

Jobbeschreibung

Hinge Bio is seeking an experienced and strategic Vice President of Regulatory Affairs to lead global regulatory strategy and execution across our pipeline of innovative biologic therapies. This individual will serve as the company's senior regulatory leader and will be responsible for developing and implementing regulatory strategies that accelerate product development while ensuring compliance with applicable global regulations.

The VP of Regulatory Affairs will partner closely with Clinical Development, CMC, Quality, Nonclinical, and Executive Leadership to guide development programs focused on immunology and oncology from preclinical stages through IND submission, early clinical development, and subsequent regulatory milestones. This leader will represent Hinge Bio in interactions with regulatory authorities, including the FDA, and will play a critical role in shaping development pathways that support efficient and successful advancement of the company's pipeline.

As a member of the senior leadership team, the VP will provide strategic regulatory input to corporate planning, business development evaluations, investor communications, and long-range portfolio strategy.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and execute global regulatory strategies for biologics from preclinical development through clinical proof-of-concept.
• Lead regulatory planning and risk assessment for development programs, ensuring alignment with corporate objectives and development timelines.
• Provide strategic guidance regarding regulatory requirements, expedited development pathways, orphan designation opportunities, and interactions with health authorities.
• Build and lead a scalable regulatory function appropriate for a growing biotechnology company.

Health Authority Interactions

• Lead preparation for and participation in FDA meetings, including Pre-IND, INTERACT, Type B, End-of-Phase, and other regulatory interactions.
• Develop briefing documents, meeting strategies, and responses to agency feedback.
• Serve as primary company contact for regulatory agencies in the United States and, as needed, international markets.
• Maintain productive and collaborative relationships with regulatory authorities.

Regulatory Operations & Submissions

• Oversee preparation, review, and submission of regulatory applications, including:
• INDs and IND amendments (or country-specific applications)
• Annual Reports
• Safety Reports
• Clinical Trial Applications
• Orphan Drug Designation applications
• Fast Track, Breakthrough Therapy, RMAT, or other expedited development requests
• Ensure regulatory submissions are high quality, compliant, and completed on schedule.
• Manage regulatory publishing and submission vendors as necessary.

Clinical Development Support

• Provide regulatory leadership for clinical development plans and protocols.
• Partner with Clinical Operations and Medical teams to ensure regulatory expectations are incorporated into trial design and execution.
• Interpret evolving regulatory requirements and communicate implications to internal teams.

Cross-Functional Collaboration

• Work closely with:
• Clinical Development
• Translational Medicine
• CMC Manufacturing
• Quality Assurance
• Legal and Compliance
• Ensure regulatory considerations are integrated into development and operational decision-making.
• Monitor evolving regulatory guidances, agency expectations, and industry trends.
• Lead regulatory inspection readiness efforts in collaboration with Quality.
• Provide regulatory training and mentorship across the organization.
• Establish and maintain regulatory SOPs and processes appropriate for stage of development.

Corporate and Strategic Contributions

• Conduct regulatory due diligence assessments for potential collaborations, licensing opportunities, and acquisitions.
• Contribute regulatory sections for fundraising presentations, partner discussions, and Board materials.
• Evaluate competitive regulatory landscapes and emerging policy developments impacting company programs.

Qualifications

Education

• Advanced degree in life sciences, pharmacy, medicine, public health, or related field preferred.
• PhD, PharmD, MD, or MS strongly preferred.

Experience

• Minimum 15 years of biotechnology, pharmaceutical, or regulatory affairs experience.
• At least 8 years in positions of increasing leadership responsibility.
• Demonstrated success leading global regulatory strategy for biologics.
• Experience preparing and leading FDA interactions and regulatory meetings.
• Direct, hands‑on experience with IND preparation, drafting and maintenance.
• Experience supporting all stages of clinical development.
• Experience in autoimmune, immunology or oncology biologics development is highly desirable.
• Prior experience within a small or emerging biotechnology company strongly preferred.

Knowledge & Skills

• Deep understanding of FDA regulations, ICH guidelines, and global regulatory requirements.
• Strong knowledge of CMC, nonclinical, and clinical regulatory requirements for biologics.
• Excellent strategic thinking and problem‑solving abilities.
• Ability to influence without authority and successfully operate in a highly collaborative environment.
• Excellent written and verbal communication skills.
• Strong project management and organizational skills.
• Ability to balance scientific rigor with business objectives.

The successful candidate will:

• Think strategically while executing effectively.
• Operate comfortably in a fast‑paced startup environment.
• Demonstrate sound judgment under uncertainty.
• Build productive relationships across functions and external stakeholders.
• Communicate clearly with scientists, clinicians, regulators, investors, and Board members.
• Inspire trust, accountability, and a culture of excellence.

Why Hinge Bio

At Hinge Bio, you will have the opportunity to shape the development pathway of innovative therapies from the earliest stages through clinical proof-of-concept. You will play a visible leadership role within a highly collaborative team dedicated to advancing transformative medicines for patients with serious diseases.