169 applicants

Company

Novo Nordisk · 6 hours ago

Specialist - Regulatory Affairs

Plainsboro, NJ

Full-time

Remote

Mid Level

$100K/yr - $125K/yr

3+ years exp

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Responsibilities

Assist Manager/Director in review of labeling for marketed products and new products as assigned

Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions

Draft more complex correspondence

Draft ROCs for more complex contacts

Prepare routine correspondence

Provide proactive support and technical assistance during preparation and review of regulatory documents

As assigned, participate in project teams

Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents

Assume additional responsibilities as applicable

Complete internet searches

Proactively manage the scope of project responsibilities, identify and compose draft correspondence relevant to projects on own initiative, such as letters of response, transmittal and memoranda where applicable. Use and contribute to development of templated correspondence as appropriate, ensuring that all new information is correct

Proactively seek and find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward

Provide proactive support in managing project

Take the initiative to assist with overflow in other areas as needed

Advise stakeholders of submission completion

Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisors’ requirements and guidance

Coordinate review of documents and follows up to resolve issues

Obtain documents/information for regulatory submissions from various functional areas and checks for errors, missing information, legibility, translations, etc.

Proactively coordinate document submission

Proactively identify issues and inform appropriate individuals

Review information from local & NNAS contributing departments and provide comments to assure that documents are accurate and complete and comply with FDA regulations

Works with manager to gather internal intelligence including tracking and maintaining the Submissions Plan update. Consolidates research and gathers Novo Nordisk opinions/position (e.g. FDA draft guidances, proposed rules). Works with manager to compose letters incorporating NN position on external regulatory initiatives

Works with Group Manager to maintain surveillance of regulatory environment and competitor development

Evaluates submission information for input into Regulatory Information Management System (RIMS) within required timelines

Responsible for maintenance reports notification for all projects/products Quarterly and Annual Safety Updates. Works with Labeling group to ensure timely completion of labeling tasks and assignments

Participates in department forum meetings e.g. CMC, PRB, and ensures that proper minutes from these meetings are available in the database. Assists with overflow in other areas as needed and handle other duties and/or special projects as assigned by Regulatory Management

Qualification

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Pharmaceutical industry experienceRegulatory submissionsMicrosoft Office SuiteProcess streamliningProject management skillsListening communication skills