Regulatory Publishing Lead: FDA Submissions & eCTD

Adweek; Bridgewater (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

Artech is seeking a Regulatory Affairs Publishing professional to publish, submit, and maintain regulatory filings in coordination with Global Regulatory Leads. The role requires ensuring compliance standards and coordinating with external consultants and health authorities.

Candidates should be proficient with MS Office, Adobe tools, and publishing software (sCubed/eCTD Manager) and have experience in electronic submissions and FDA Gateway dispatch.

Qualifications

• Bachelor's degree in regulatory affairs, sciences, or related area and relevant experience.
• Four years of submission publishing experience.
• Strong knowledge of regulatory filings in electronic submission environments.

Responsibilities

• Publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads.
• Ensure compliance standards for receipt and delivery of information to external consultants and health authorities.
• Publish and archive submissions; coordinate with submission components and peer reviews.
• Assist in planning, development and publishing of submissions; dispatch through FDA Gateway.

Skills

MS Office

Adobe Professional

Adobe Add-ins

Publishing Software

Validation Tools

Document Management Systems

Regulatory knowledge

Education

Bachelor's degree in regulatory affairs or related

Tools

sCubed

eCTD Manager

MS Office

Adobe Acrobat Pro

Job description

Artech is seeking a Regulatory Affairs Publishing professional to publish, submit, and maintain regulatory filings in coordination with Global Regulatory Leads. The role requires ensuring compliance standards and coordinating with external consultants and health authorities.

Candidates should be proficient with MS Office, Adobe tools, and publishing software (sCubed/eCTD Manager) and have experience in electronic submissions and FDA Gateway dispatch.