Business Analyst Regulatory Submissions Specialist at Computer Doc Associates in East Hanover, NJ

Computer Doc Associates, Inc

East Hanover, NJ
Depends on Experience
October 27, 2020

You will be redirected to Computer Doc Associates, Inc's preferred application process.

BusinessAnalyst Regulatory Submissions Specialist

Job Description

As a Business Analyst in Regulatory Submissions, you will be responsible for supporting business decisions by working closely with service deliver groups (such as IT, Reporting, etc.,) to establish initiatives and strategies to improve and optimize daily operations and reduce project costs. The ideal candidate will need a strong understanding of regulatory and reporting requirements in a pharmaceutical environment as well as the understanding of key performance indicators. Responsibilities and


Prior experience in tracking for regulatory submission for Global marketed products is a must Candidate will represent Client to ensure the proper entry of all information in alignment with process. Plan, and track status of regulatory submissions (variations supplements), regulatory impact for variations, publishing requests with creation of core packages and related administrative activities, including information and data entry and uploading submission documentation. Maintain up-to-date Client registration tracking including updates to registered information and report on approval status and Health Authority correspondences. Handle and precisely maintain registration tracking activities including creation, initiation of workflow, closing and archiving in Vault. Communicate effectively with Clientrsquos managers. Defining Business requirements that outline problems, opportunities, and solutions to meet business objectives. Planning and monitoring of solutions to meet business needs. Reporting to stakeholders and senior leads. Identifying and prioritizing technical and functional requirements. Collaboration and partnership with other services lines. Experience in the diagnostics or pharmaceutical industry focusing on quality system procedures, regulatory affairscompliance, controlled documentation, product labeling, or change control. Strong written and verbal communication skills Proficiency in word processing, spreadsheet, database, e-mail software, and use of appropriate software tools such as MS Office suite. Ability to read and draft complex documents proofing materials. Must possess strong interpersonal skills and be a team player. Ability to multitask and prioritize. Exp. With labeling systems and software. (Key responsibilities, authorities, and inter-relationships) Drives the compilation and publishing of regulatory submissions within specified deadlines. Ensures the quality of submissions generated. Provides expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaises with internal organizations to providesolicit guidance and support for complex submissions. Collaborate into project teams, driving timelines and deliverables related to submission documents. Interfaces with technical staff to facilitate and prioritize the development of domestic andor global submissions. Assures that a positive working relationship is developed and maintained between staff and internalexternal customers. Develops and maintains high level relationships with key contacts in regulatory agencies.
Experience and


Requirements Bachelors degree in Engineering, Science or related field is required. Masters of Science in Engineering, Science or related field or MBA is preferred. minimum of 5-7 years of experience in regulatory affairs or related functions in an FDA regulated industry is required. Ten or more years of related experience is preferred. Must have strong organizational skills. Must demonstrate effective written and verbal communication skills, including technical writing skills. Must have knowledge of regulatory submissions including 510k notifications and pre-market approval applications.


You will be redirected to Computer Doc Associates, Inc's preferred application process.

Job Expires: November 26, 2020

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You will be redirected to Computer Doc Associates, Inc's preferred application process.