Regulatory Intelligence Analyst

Summary

Join Veeva Systems, a leading life sciences industry cloud company, as a Regulatory Intelligence Analyst. You will collaborate with a team to ensure product compliance with global health authority regulations. Key responsibilities include identifying, monitoring, and interpreting regulatory changes, communicating these changes to internal teams, and working with product management on compliance features. The ideal candidate possesses 3+ years of experience in relevant life sciences roles, strong analytical and communication skills, and a detail-oriented approach. Veeva offers a flexible work environment and competitive benefits, including health insurance, paid time off, retirement programs, and a charitable giving program. The role is based on the East Coast of the US or Canada, with occasional travel.

Requirements

• 3+ years experience in one or more of the following industries and roles: commercial software (e.g., product management, solutions consulting, customer success), quality assurance, CMC, clinical development (e.g., clinical operations), pharmacovigilance, regulatory affairs, or regulatory operations in the life sciences industry
• Working knowledge of regulatory processes and procedures in at least one regulated sector of the life sciences industry (e.g., regulatory, clinical, commercial, quality, pharmacovigilance, CMC)
• Excellent research, analysis, and interpretation skills, with a strong ability to discern high-quality source information from low
• Excellent verbal and written communication and presentation skills, with the ability to translate complex regulatory requirements into easy-to-understand information for multiple internal teams
• Highly organized with exceptional attention to detail
• Self-starter, driven, and able to work independently as well as part of a team
• Excellent working skills with office software (e.g., MS Office, Google Suite)
• Willingness to travel occasionally to Veeva offices
• Located on the east coast of the United States or Canada

Responsibilities

• Identify regulatory requirements related to the product and implement best practices for monitoring, interpreting, and communicating changes to internal teams
• Proactively monitor, investigate, interpret, and communicate changes to regulatory requirements that may impact the current product
• Proactively monitor the global regulatory landscape for upcoming health authority initiatives or projects that may impact the product in the future
• Work directly with product management to translate regulatory requirements into Veeva’s framework for use within our suite of applications
• Translate long and complex regulatory guidance into clear, concise, and easy-to-understand information for different internal teams
• Work with a team of Regulatory Intelligence Analysts to continually improve the processes and tools used for collecting, documenting, managing, and communicating regulatory intelligence

Preferred Qualifications

• Experience working with Veeva’s products and processes
• Experience working in a dedicated regulatory intelligence role in the life sciences industry
• Experience working with or for a health authority (e.g., Health Canada, FDA, EMA)
• Additional experience in other regulated product areas (e.g., clinical in addition to regulatory, or quality in addition to CMC)

Benefits

• Medical, dental, vision, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program