Senior Associate/Manager, Regulatory Affairs

The role:

The Senior Associate/Manager, Regulatory Affairs will be a key individual contributor on a small, high-impact regulatory team and will report directly to the Vice President, Head of Regulatory Affairs. This role is highly hands-on and will support the full breadth of regulatory activities across global development programs.

The Senior Associate/Manager will play a critical role in shaping regulatory strategy, authoring and managing regulatory documents, supporting regulatory operations, and keeping the teams up to date on regulatory landscape. This individual will work cross-functionally with Clinical Development, CMC, Quality, Research, and external partners such as CROs, Medical Writers and Regulatory Operations.

Key responsibilities:

• Author, review, and manage technically complex regulatory submissions, including investigational new drug applications (IND), amendments, meeting briefing packages, annual reports, and responses to health authority questions for our DISP-10 program in solid tumors
• Serve as a regulatory core team member on study teams, providing guidance to cross-functional stakeholders on regulatory requirements and risks
• Support health authority interactions (e.g., FDA, TGA), including preparation for and participation in meetings and other health authority interactions
• Manage regulatory operations activities, including preparing document submissions, submission planning, and maintenance of regulatory archives
• Contribute to and execute global regulatory strategies for our lead asset from early development through clinical stages
• Track, assess, and communicate relevant regulatory intelligence, guidance, and policy trends impacting oncology and cell therapy development
• Support interactions with external partners, including CROs and regulatory vendors, ensuring alignment with regulatory strategy and timelines
• Ensure regulatory activities are compliant with applicable regulations, guidelines, and internal processes
• Contribute to continuous improvement of regulatory processes, tools, and templates appropriate for a growing organization

Required experience & skills:

• Bachelor’s degree in life sciences or related discipline
• Minimum of 2 years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry for Senior Associate level
• Minimum of 5 years of Regulatory Affairs experience within the bio/pharma industry for Manager level
• Direct experience supporting oncology drug development, including IND-stage programs
• Ability to independently drive projects while knowing when to escalate or seek alignment
• Hands-on experience authoring and managing regulatory submissions and health authority correspondence
• Strong understanding of FDA regulations and ICH guidelines relevant to clinical-stage development
• Excellent written and verbal communication skills, with strong attention-to-detail
• Highly organized, with the ability to manage multiple priorities in a fast-moving environment
• Collaborative, proactive, and comfortable operating in a small, resource-constrained startup setting

Preferred experience & skills: 

• Advanced degree (MS, PHD, PharmD)
• Prior experience with cell therapy or advanced therapy medicinal products (ATMPs)
• Experience working in early-stage or startup biotech environments
• Direct experience supporting solid tumor drug development
• Direct experience preparing original IND submissions
• Exposure to global regulatory development (e.g., EMA or other ex-U.S. agencies)
• Experience supporting regulatory aspects of CMC and manufacturing activities for cell therapies