Regulatory Publishing Manager

• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development support to project teams and the regulatory community.

• The focus of this position will be to publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads.

• The role works to tight, business-critical deadlines within a highly regulated environment.

• She/he also ensures that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities.

• Expert in publishing capabilities of all modules with a competency in the component locations within the eCTD backbone structure

• .Support Global Regulatory Leads in the planning, development, and publishing of submissions.

• Control submission component receipt and workflow completion to ensure a high quality final submission.

• Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.

• Coordinate publishing tasks associated with assigned submissions, including peer review of submissions generated by other publishers.

• Ability to contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch.

• Dispatch submissions through the FDA Gateway

• Ensure adherence to internal and external standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the application.

• Archive submissions both electronic and paper.

Skills: 

• Proficient in use of MS Office, Adobe Professional, Adobe Add-ins, Publishing Software (sCubed and/or eCTD Manager), Validation Tools and Document Management Systems.

• Demonstrate ability to function autonomously in a matrix environment.

• Knowledgeable in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions.

• Must be detail oriented and articulate with strong analytical, decision-making, and interpersonal skills.

• Demonstrate regulatory knowledge and awareness, technical competence, sound judgment, and a professional demeanor.

• Demonstrate flexibility in dealing with change and diversity.

• Ability to multi-task in a fast paced environment.

• All candidates should have an understanding of the concepts around regulatory affairs and significant knowledge of submissions processes.

• Proficient in formatting Word documents prior to publishing and electronic navigation for Adobe documents.

Education:

At least a bachelor s degree, or equivalent, in regulatory affairs, the sciences, or related areas of study, and relevant experience. Four years submission publishing experience.

Best Regards,

Anuj Mehta

973-967-3402