Regulatory Document Publishing Senior Associate

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.

Responsibilities

• 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

Requirements/Skills

• 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 bria.gaber@investigo-us.com & (646) 430-1191.