Regulatory Publishing Manager

Adweek; Bridgewater Township (NJ); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

Attention to detail

Analytical skills

Multi-tasking

Communication

Interpersonal skills

Autonomy in matrix environment

Educación

Bachelor's degree in regulatory affairs or related field

Herramientas

MS Office

Adobe Acrobat Pro

Adobe Add-ins

Publishing Software (sCubed/eCTD Manager)

Validation Tools

Document Management Systems

Descripción del empleo

Company Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

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 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.

Additional Information

Best Regards,

Anuj Mehta

973-967-3402