Be part of our team
As the Senior Manager/Associate Director, Regulatory Operations, you will be responsible for the execution of Regulatory Submissions operational activities in support of our program(s), ensuring adherence to current electronic submission guidelines/requirements.
This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and oversight of our electronic submissions (eCTD) vendor, and management of Regulatory archives, submission templates, and Agency correspondence. Support the preparation and submission of Investigational New Drug applications (INDs), Biologic License applications (BLAs), annual reports, Development Safety Update Reports (DSURs), Investigator's Brochure (IB), briefing books to regulatory authorities.
This position will report to the Senior Vice President, Regulatory Affairs within the Clinical Development department and be based in Boston, MA or possible remote opportunities within MA, NY, PA, RI, NJ, NC or FL.
Why us?
At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.
- Impact that matters: Contribute to breakthrough therapies.
- Global mindset: Work in an international, diverse team.
- Grow & thrive: Develop your career in a supportive, fast-moving environment.
- Innovation every day: Push boundaries with cutting-edge science.
At Tubulis, your ideas matter, your growth matters—and together, we make a difference.
About us
Tubulis is a clinical stage biotech company that generates uniquely matched antibody-drug conjugates (ADCs) with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. We recently closed on a Series C fundraising round totaling €344M (US $401M).
The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and ADCs. With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.
