Senior Specialist - Regulatory Submissions Management
$73,600–$110,400 year
Remote · United States
Job Summary
Senior Publishing Specialist within Regulatory Submissions Management will provide regulatory submission publishing services, serve as a key point of contact for Regulatory Operations customers, ensure right-first-time submission quality and timeliness, and use Veeva for Registrations to plan/track submissions. You will liaise with Regulatory Affairs and local affiliates, collaborate with regional counterparts for global worksharing, guide junior staff on submission publishing, document management (Veeva Vault) and submission-ready document standards, and monitor evolving agency guidance and regulations. Travel is required up to 5% and relocation is not provided. US-based employment requires legal work authorization.
Required Qualifications
- 2+ years of Submission Publishing and Submission Management principles
- Hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault)
- Proficiency in spoken and written English
Additional Requirements
- US work authorization required to be employed in the United States
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