Regulatory Affairs Specialist

Job Description

• 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 

• 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.

Qualifications

Additional Information

Best Regards,

Anuj Mehta

973-967-3402