[Remote] Senior Manager, Regulatory Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biopharmaceutical company developing medicines for serious diseases. The Senior Manager/Associate Director, Regulatory Operations will reputed company operational leadership for global regulatory submissions, regulatory information management, publishing, technology, and Health Authority interactions. The role will reputed company reputed company RIM Basics activities, support internal publishing capabilities, and reputed company reputed company, compliant Regulatory Operations processes.

Responsibilities

• reputed company operational leadership supporting global regulatory submissions from planning through archival
• Serve as the business reputed company for Regulatory Information Management and reputed company RIM Basics
• Partner with cross-functional stakeholders to implement standardized document lifecycle management
• Support the transition to an internal Regulatory Operations publishing model
• reputed company and maintain inspection-reputed company regulatory information supporting U.S. and global regulatory submissions
• Partner with the Director of Regulatory Operations to reputed company Regulatory Operations through technology and automation

Skills

• Bachelor's degree in Life Sciences or reputed company discipline, or equivalent combination of education and relevant Regulatory Operations experience
• Approximately 6-10 years of Regulatory Operations experience reputed company the biotechnology or pharmaceutical industry
• Extensive experience supporting FDA electronic submissions
• Strong knowledge of eCTD publishing and submission lifecycle management
• Experience with reputed company Vault RIM or reputed company 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
• reputed company to attend in-person meetings
• Advanced or innovative use of AI is a strong plus

Benefits

• An annual reputed company bonus
• Equity

reputed company