Senior Manager, Commercial Regulatory Operations

Responsibilities:
- Manage the end-to-end content review and approval process for promotional and non-promotional materials using the Veeva document management system
- Drive process improvement and operational efficiency initiatives within the CRT workflow
- Support system maintenance and enhancements in Veeva PromoMats and MedComms (administrative updates and light configuration changes)
- Partner with Marketing on the development and maintenance of claims and reference libraries
- Collaborate with Regulatory, Medical, and Legal to maintain CRT workflows for product and disease-related content proposed by Marketing/Medical Affairs and agencies
- Plan and facilitate CRT meetings (agenda creation, calendar coordination, expedited review processing, material quality checks, consensus documentation)
- Prepare timely and accurate FDA Form 2253 submissions (with Regulatory colleagues)
- Monitor and report on approval metrics; support prioritization and capacity planning
- Provide onboarding and training for CRT reviewers and content creators
- Provide project oversight and vendor management for ongoing Veeva system enhancements and upgrades

Preferred Skills, Qualifications and Technical Proficiencies:
- Expertise in Veeva PromoMats/MedComms and promotional/non-promotional material review processes
- Ability to manage without direct authority and influence colleagues
- Excellent analytical, problem-solving, and communication skills
- Highly organized, detail-oriented, and adaptable

Preferred Education and Experience:
- BA/BS in health/life sciences or related field
- 6+ years in pharmaceutical/life sciences/related industry; leading or supporting review committee meetings
- Product launch and pre-approval commercialization experience
- Experience in AI implementation, claims library maintenance, and Veeva administrative support

Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.