Note: The job is a remote job and is open to candidates in USA. Parabilis Medicines is a clinical-stage biopharmaceutical company developing medicines for serious diseases. The Senior Manager/Associate Director, Regulatory Operations will provide operational leadership for global regulatory submissions, regulatory information management, publishing, technology, and Health Authority interactions. The role will lead Veeva RIM Basics activities, support internal publishing capabilities, and develop scalable, compliant Regulatory Operations processes.
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
Skills
- 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
- Able to attend in-person meetings
- Advanced or innovative use of AI is a strong plus
Benefits
- An annual target bonus
- Equity
Company Overview