Regulatory Submissions Publisher - eCTD & FDA Expert

Adweek; Bridgewater Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

Artech is seeking a Regulatory Affairs Operations professional to publish, submit, and maintain regulatory filings in coordination with Global Regulatory Leads. You will manage submissions to the FDA gateway, adhere to ICH and FDA guidelines, and meet tight deadlines in a highly regulated environment.

The ideal candidate has a bachelor’s degree in regulatory affairs or related fields and at least four years of submission publishing experience; strong detail orientation, analytical skills, and

Qualifications

• At least a bachelor’s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study.
• Four years submission publishing experience.
• Experience with ICH and FDA regulations for electronic submissions.
• Must be detail oriented with strong analytical and interpersonal skills.

Responsibilities

• Publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads.
• Coordinate publishing tasks and peer review submissions.
• Ensure adherence to SOPs, guidance documents, and policies throughout the submission lifecycle.
• Dispatch submissions through regulatory gateways (FDA Gateway) and archive electronic and paper submissions.
• Identify issues early and support resolution before filing dates.
• Support planning, development, and publishing of submissions.
• Operate within a matrix environment autonomously and collaboratively.

Skills

Regulatory knowledge

Attention to detail

Analytical skills

Multi-tasking

Communication

Interpersonal skills

Autonomy in matrix environment

Education

Bachelor's degree in regulatory affairs or related field

Tools

MS Office

Adobe Acrobat Pro

Adobe Add-ins

Publishing Software (sCubed/eCTD Manager)

Validation Tools

Document Management Systems

Job description

Artech is seeking a Regulatory Affairs Operations professional to publish, submit, and maintain regulatory filings in coordination with Global Regulatory Leads. You will manage submissions to the FDA gateway, adhere to ICH and FDA guidelines, and meet tight deadlines in a highly regulated environment.

The ideal candidate has a bachelor’s degree in regulatory affairs or related fields and at least four years of submission publishing experience; strong detail orientation, analytical skills, and