Senior Regulatory Operations Lead: Submissions & RIM

Parabilis Medicines; Cambridge (MA); In loco; USD 145.000 - 175.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity

Competitive benefits

Descrizione del lavoro

Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical Writing, Clinical Development, CMC, and Quality to ensure compliant, timely submissions.

The role emphasizes strong technical regulatory operations expertise, process improvement, and partnering with external providers.

Competenze

• Bachelor’s degree in Life Sciences or related discipline or equivalent experience.
• Approximately 6–10 years in Regulatory Operations within biotech/pharma.
• 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 expected.

Mansioni

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

Conoscenze

Regulatory Operations

Project management

Communication

Collaboration

AI in daily work

In-person meetings

Formazione

Bachelor's degree in Life Sciences or related discipline

Strumenti

Veeva Vault RIM

Veeva RIM Basics

eCTD publishing

Descrizione del lavoro

Parabilis Medicines is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions, information management, and publishing initiatives. You will drive Veeva RIM implementations and collaborate across Regulatory Affairs, Medical Writing, Clinical Development, CMC, and Quality to ensure compliant, timely submissions.

The role emphasizes strong technical regulatory operations expertise, process improvement, and partnering with external providers.