Senior Manager, Regulatory Operations (Records & Information Management)

The Opportunity:

The Sr. Manager, Regulatory Operations (Archiving & Information Management) is a senior individual contributor role responsible for the compliant management, classification, and retrieval of regulatory submissions and health authority correspondence across the product lifecycle. This role serves as the subject matter expert for regulatory correspondence, archival standards, and metadata governance within Veeva Vault Regulatory Information Management (RIM), with accountability for metadata consistency and inspection readiness. Core responsibilities include defining and enforcing archival and metadata standards, overseeing regulatory archiving activities, enabling and training Regulatory Affairs users to correctly classify records, and supporting inspections and business development due diligence through accurate, complete, and readily retrievable regulatory records.

While this role is currently centered on hands-on regulatory archiving and correspondence management, it is expected to evolve over time as automation and system maturity increase, with greater emphasis on regulatory information management and metadata strategy within Veeva Vault RIM. Accountability for the integrity, consistency, and retrievability of regulatory records will remain constant throughout this evolution.

• Serve as the subject matter expert for regulatory submissions and health authority correspondence, including interpretation and classification of correspondence types (e.g., Information Requests, Study May Proceed letters, amendments, safety communications).

• Execute and oversee the archiving of regulatory submissions and correspondence, ensuring accuracy, completeness, and retrievability throughout the record lifecycle.

• Define, maintain, and enforce archival and metadata standards, including controlled vocabularies and classification conventions, within Veeva Vault RIM.

• Monitor regulatory metadata quality and consistency across the system; identify, investigate, and drive remediation of data quality issues.

• Enable and train Regulatory Affairs staff and partners on proper document classification, metadata entry, and archival best practices.

• Support inspection readiness activities by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable.

• Respond to regulatory documents and correspondence requests in support of business development due diligence, licensing, and partnership activities.

• Support Veeva Vault RIM business owners as needed.

• Partner cross-functionally with Regulatory Affairs, Quality, IT, and other stakeholders to continuously improve regulatory archiving and information management processes.

• Contribute to the development and maintenance of SOPs, work instructions, and best practices related to regulatory archiving and records management.

Required Skills, Experience and Education:

• Bachelor’s degree required; advanced degree preferred.

• Minimum of 7–10 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or related functions within the pharmaceutical or biotechnology industry.

• Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management.

• Strong working knowledge of global regulatory submissions and health authority correspondence processes.

• Proven ability to apply archival standards and metadata practices in a regulated environment.

• Experience supporting inspection readiness and responding to regulatory or business-critical document requests.

• Strong attention to detail, organizational skills, and ability to manage work independently in a fast-paced environment.

• Excellent written and verbal communication skills, including the ability to train and guide cross-functional stakeholders.

Preferred Skills:

• Prior experience with regulatory submission publishing processes; hands-on publishing experience a plus.

• Experience supporting regulatory due diligence activities for business development, licensing, or mergers and acquisitions.

• Familiarity with records retention policies and regulatory archival requirements.

• Experience working in emerging or mid-size biotechnology organizations.

• Experience contributing to process improvement initiatives related to regulatory systems or information management. 

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