Senior Manager, Regulatory Operations

About Parabilis Medicines

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The company has pioneered a new class of alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that have historically been beyond the reach of conventional medicines. The company’s lead investigational medicine, zolucatetide, is the first and only direct inhibitor of the β-catenin:TCF interaction, a central node in the Wnt/β-catenin pathway that has eluded drug developers for decades. Zolucatetide is being evaluated in the clinic across multiple Wnt/β-catenin-driven diseases, including desmoid tumors, familial adenomatous polyposis (FAP) and a range of other solid tumor indications. Beyond zolucatetide, Parabilis is advancing additional Helicon-based programs focused on other challenging targets where we believe our medicines could have life-altering impact. For more information, visit www.parabilismed.com or follow us on LinkedIn.
What’s the opportunity?

We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you will provide operational leadership supporting global regulatory submissions, regulatory information management, regulatory technology, publishing, and Health Authority interactions across development programs.

This individual will serve as the business lead for Regulatory Information Management, supporting implementation and optimization of Veeva RIM Basics while helping establish internal publishing capabilities and scalable Regulatory Operations processes.

The successful candidate will combine strong technical Regulatory Operations expertise with systems implementation experience, regulatory publishing knowledge, and a passion for process improvement. This role will partner closely with Regulatory Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality, compliant, and timely regulatory submissions.
Key responsibilities:

- Provide operational leadership supporting global regulatory submissions from planning through archival.

- Serve as the business lead for Regulatory Information Management and Veeva RIM Basics.

- Partner with cross-functional stakeholders to implement standardized document lifecycle management.

- Support the transition to an internal Regulatory Operations publishing model.

- Develop and maintain inspection-ready regulatory information supporting U.S. and global regulatory submissions.

- Partner with the Director of Regulatory Operations to modernize Regulatory Operations through technology and automation.

What you’ll need to be successful:

- Bachelor's degree in Life Sciences or related discipline, or equivalent combination of education and relevant Regulatory Operations experience.

- Approximately 6-10 years of Regulatory Operations experience within the biotechnology or pharmaceutical industry.

- Extensive experience supporting FDA electronic submissions.

- Strong knowledge of eCTD publishing and submission lifecycle management.

- Experience with Veeva Vault RIM or Veeva RIM Basics.

- Experience supporting regulatory information management systems.

- Experience supporting global submissions, including CTAs and Health Authority interactions.

- Experience training end users on regulatory systems.

- Experience developing Regulatory Operations processes and SOPs.

- Strong project management and organizational skills.

- Excellent communication and collaboration skills.

- Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus.

- Able to attend in-person meetings.

Core Values

Parabilis Medicines is a team of passi