Head of Regulatory Affairs

About Us

Kali Therapeutics embodies transformation and renewal, inspired by the Hindu goddess Kali, symbolizing power and rebirth. Focused on groundbreaking advancements in immunotherapy, Kali Therapeutics specializes in T-cell engagers and other innovative therapies that address high unmet medical needs. About The Role The Executive Director/VP of Regulatory Affairs reports to the CMO and is responsible for leading the global company’s regulatory strategy and working closely with cross functional leaders in all regulatory interactions and activities for the development of our therapeutic candidates. The position includes responsibility for the development and refinement of regulatory strategy working in collaboration with senior management, to ensure compliance with applicable global regulations, standards, and clinical practice guidelines. This position is responsible for providing regulatory oversight for the management of clinical trial applications and filings, and will work closely with various partners, consultants, CROs, and local and global health authorities to ensure rapid review and approval of global clinical trial applications, and other applicable regulatory filings. What You'll Do:

• Serve as the global regulatory lead for development programs.
• Lead cross functional activities related to company & program strategy, including providing input on implications of regulatory strategy through participation in product development teams.
• Serve as regulatory lead in health authority interactions, manage all correspondence with health authorities and the RA coordination with partner companies and vendors.
• Provide strategic regulatory guidance regarding applicable expedited regulatory pathways to product development teams.
• Prepare, review, and coordinate regulatory documents, to include but not limited to Information Requests, IND submissions, Annual Reports, ensure that all sections of CMC and clinical documents are complete, well-written, and meet all relevant regulatory requirements.
• Perform critical review of submission documents to ensure compliance with regulatory requirements.
• Coordinate and manage submission planning with regulatory publisher.
• Provide input into strategy with respect to nonclinical data package, planned therapeutic indication(s), patient population, clinical study design and regulatory strategy to support product development teams.
• Provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for IND submissions, clinical trial applications (CTAs) and registrational strategies for development projects.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Identify, communicate, and propose resolutions to both routine and complex issues.
• Monitor regulatory developments within the industry and anticipate and communicate possible global regulatory paradigm shifts.

What You'll Bring:

• BS/BA degree (or equivalent) in a relevant scientific field required, with an advanced degree preferred.
• 15+ years of experience in regulatory function, across large pharma and small biotech industry with hands-on experience and knowledge of the drug development of biologics and small molecules in autoimmune and oncology therapeutic areas
• Strong communication and interpersonal skills.
• In depth knowledge of FDA, NMPA, and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• Must be capable of developing and implementing regulatory strategies and of managing complex negotiations with Regulatory Authorities.
• Prior global regulatory experience required.
• Therapeutic area experience in oncology and/or autoimmune disease is desired.
• Experience writing and developing SOPs.
• Demonstrated ability to: develop/maintain strong working relationships with cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
• Detail-oriented while also retaining the ability to see the big picture.
• Flexible with demonstrated ability to work in a fast-paced, timeline-driven environment.
• Effective technical/analytical skills to identify and solve problems independently.
• Proven ability to manage multiple projects, identify and resolve regulatory issues as they arise.
• Proven ability to effectively collaborate with internal team and external collaborators.
• Will work tirelessly to foster an environment of transparency and direct dialogue.

Kali is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. At Kali we engage in equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. We take care of our employees with a competitive benefits package that provides medical, dental, and vision coverage for employees and their dependents, as well as 401(k) plans.