The role:The Senior Associate, 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 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
- 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
Our values: Our values guide everything we do. While capabilities and skills are vital, understanding how a potential new colleague would embody our values is central to our hiring decisions.
Determined to deliver: By working with focus and passion, we can provide patients with the solutions they need.
Own every outcome: We can reach new heights when we stay centered on our shared success.
Collaboration at the core: When we band together, our work is better.
Feedback is fundamental: Constructive and authentic positive feedback may be difficult to master but it is vital to our success.
Working here:- We offer a highly competitive compensation package with meaningful ownership through equity
- Excellent coverage for medical, vision, and dental
- 401(k) with generous contribution
- Life insurance
- Flexible PTO policy
- Additional substantial benefits
