Senior Associate, Regulatory Document Publishing (Regulatory Operations)
New Jersey - United States
Seeking an experienced and highly eager Regulatory Document Publishing professional for a Global Regulatory Operations group in NJ. Looking for a strong candidate to be responsible for various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Will be a part of the document strategy and expected to provide support for the preparation, compilation, QC work for internal and external sources.
- Assist in the in the document preparation for dossiers and publishes electronic submissions in eCTD, or non-eCTD format, for FDA, EMA and other regulatory agencies.
- Involved in and supports all regulatory documents publishing programs, templates, and project planning applications.
- Use of Internal and External Publishing Tools to creates CSR appendices.
- Support RIM users by leveraging top support and value from the Veeva Vault RIM suite of product systems
- Manage all user accounts in the RIMS system regarding all user permissions and restrictions and security profiles
- Interfaces with system and users to detect necessary ad hoc regulatory and compliance-related system updates; resolve any relevant request
- Bachelor's degree or equivalent experience is required with at least 3-5 years of Regulatory Affairs and/or Regulatory Operations experience required within a pharmaceutical/biotech setting.
- Regulatory Publishing experience is required.
- US and EU submissions knowledge and experience.
- Formatting and document template authoring experience.
- Veeva Vault Regulatory Information Management software or equivalent preferred
- DocuBridge publishing software proficiency
- Direct experience and working knowledge of regulatory submissions requirements within pharmaceutical/biotech, per global health authorities and ICH guidelines.
- Well-versed and experienced within FDA regulations and other outside agencies
- Experience with preparing all type of regulatory documentations relative to submission needs
- Expertise and knowledge with eCTD/CTD
- Understanding of the Quality Assurance (QA) function as it applies to regulatory documents including the ability to review and QC documents intended for regulatory submissions.
- Strong customer service and communication skills, along with proven organizational skills in the prioritizing of multiple responsibilities with immediate deadlines
- Proven successful in a cross-functional environment.
If you'd like to be considered for this position or interested in learning more, please contact Bria Gaber directly at email@example.com & (646) 430-1191.