Remote Otter LogoRemoteOtter

Sr. Regulatory Document Formatting Specialist - Remote

Posted 5 days ago

Overview

This role in Regulatory Operations will format and finalize documents for regulatory submissions. Ideal candidates will have experience formatting complex documents, in-depth understanding of Microsoft Word and Adobe Acrobat Pro, and familiarity with using document templates.

In Short

  • Produce high quality documents within established time frames.
  • Use Word to format documents that include tables of contents, headers and footers, links, styles, figures, and multiple-page tables.
  • Work in a collaborative authoring environment (Veeva RIM).
  • Review documents for consistent formatting according to internal templates and style guide.
  • Maintain the list of literature for regulatory submissions.
  • Communicate effectively with the Regulatory team and other functional groups.
  • Interact with the external publisher to support publishing of regulatory submissions.
  • Assist with Regulatory Operations efforts to implement and improve systems, processes, and/or tools.

Requirements

  • Minimum 8 years of industry experience and at least 2 years in Regulatory Operations.
  • Comprehensive knowledge of formatting and document assembly using MS Word.
  • Proficient with Adobe Acrobat Pro, PowerPoint, and Excel.
  • Excellent attention to detail and organizational/time-management skills.
  • Must work well with others and be accountable, adaptable, and dependable.
  • Accustomed to fast-paced, highly regulated environment.
  • Familiarity with Veeva RIM is a plus.
  • Experience using document templates; familiarity with OmniTemplates a plus.
  • Sound business ethics required.

Benefits

  • Opportunity to work in a mission-driven company.
  • Collaborative work environment.
  • Engagement in innovative vaccine development.

Similar Jobs:

Golden Hippo logo

Regulatory Specialist - Remote

Golden Hippo

4 weeks ago

The Regulatory Specialist ensures compliance with regulations for Pet Food/Supplement products and supports international market requirements.

Regulatory Compliance
PET Food Regulations
AAFCO
Food Safety
Worldwide
Full-time
All others
$64,500 - $86,000/year
Exactech logo

Regulatory Specialist - Remote

Exactech

24 weeks ago

The Regulatory Specialist will ensure compliance with regulatory requirements for medical devices and support product development projects.

Regulatory Specialist
FDA Compliance
ISO Standards
Medical Devices
United States
Full-time
All others
Mom's Meals logo

Regulatory Specialist - Remote

Mom's Meals

119 weeks ago

The Regulatory Specialist will ensure compliance with regulatory guidelines and provide guidance to the company.

Regulatory Compliance
JD
Reporting
Guidance
USA
Full-time
Finance / Legal
$108,003 - $162,005/year
anchorage logo

Regulatory Reporting & Exam Management Specialist - Remote

anchorage

1 week ago

Join Anchorage Digital as a Regulatory Reporting & Exam Management Specialist to ensure compliance across global operations in the digital asset space.

Regulatory Compliance
BSA
AML
KYC
Worldwide
Full-time
Finance / Legal
Confirmo logo

Digital Regulatory Specialist - Remote

Confirmo

7 weeks ago

Join Confirmo as a Digital Regulatory Specialist to ensure compliance with crypto regulations and lead the implementation of DORA.

Regulatory Compliance
DORA
GDPR
ISO 27001
Czechia
Full-time
Finance / Legal