Vice President Regulatory Affairs

Job Description

Role:

The Vice-President, Regulatory Affairs provides strategic and operational leadership to support product development across the organization. In this role, you will lead interactions with global regulatory agencies, coordinate with internal senior stakeholders, and manage and direct all regulatory strategic and operational initiatives.

Responsibilities:

• Lead the development and execution of global regulatory strategies.
• Provide leadership in aligning regulatory strategies with corporate goals and business objectives.
• Contribute to company culture, strategy, and operations as a member of the management Team.
• Oversee the preparation and submission of all global regulatory filings, including INDs, CTAs, Investigator's Brochures (IBs), DSURs, and BLAs.
• Manage electronic submission vendor.
• Maintain company records of all submissions and correspondence.
• Work with head of CMC to oversee regulatory strategies and regulatory submissions (INDs/IMPDs) for investigational drug products.
• Serve as the primary point of contact for global regulatory authorities (e.g., FDA, EMA, etc.), leading all communications and meetings.
• Strategize, lead, write, and/or supervise the development and submission of documents or plans (e.g. Orphan, Break-Through, Fast-Track, Accelerated-Approval) to regulatory agencies to support development goals.
• Collaborate with cross-functional teams (Clinical Development, CMC, Quality Assurance, external consultants) to ensure regulatory compliance throughout the development process.
• Provide expert guidance and support to internal stakeholders on all regulatory matters.
• Stay current on relevant evolving global regulations and guidance.
• Develop and manage the Regulatory Affairs department budget.
• Maintain active INDs/CTAs.
• Manage and collaborate with consultants and CRO partners involved in preparing US and Ex-US regulatory submissions.
• The role requires someone with hands-on experience who is comfortable rolling up their sleeves and not just delegating to others.

Requirements

• Advanced degree (Ph.D. or equivalent) or at least 25 years of biotech/pharmaceutical industry experience.
• Minimum 10 years regulatory affairs experience.
• At least 2 years regulatory affairs experience in cellular therapies.
• Prior work at a regulatory agency (e.g. CBER or CDER).
• Prior leadership of IND/BLA/MAA submissions.

Company Description

BriaCell Therapeutics Corp is a clinical stage immuno-oncology company that is developing an entirely new class of targeted immunotherapies to transform cancer care.