Regulatory Affairs Specialist

Raritan, NJContract Duration: 12-36 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a Regulatory Affairs Specialist in the Raritan, NJ area.Input in development, post-approval and life cycle managementParticipate in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy.Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.Work with the regional staff and LOCs to support regional and local activities.Assist in the preparation of meetings with Regulatory Agencies.Input in document and process developmentAssist in the development of processes related to regulatory submissionsDrafts and reviews document content (depending on level of regulatory knowledge/expertise)Provide input to documentation to ensure they are in line with product strategy and thoroughly and accurately answers the questions being posedTracks dates of submissions and Regulatory Agency responses.Advises team on required documents in preparation of CTAsProvides operational support for the assembly and distribution of submissions (e.g., Clinical trial applications for China, Health Authority Responses)Ensure CTA submission packages are complete and available according to agreed timelines.Marketing Authorization ApplicationsProvides regulatory support throughout registration process and life-cycle management (e.g. iCTDs, ACTDs, renewal applications, Health Authority Responses, site registrations and routine marketed product submissions including PSURs, RMPs)Advises team on required documents in preparation of submissions as assignedAssists with timely registration dossier availability, ensures that all document components are in place on time, identifies and tracks critical path activitiesCompiles Module 1 for iCTDs to be dispatched to countriesManages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.Responsible for the critical review of submission documents to ensure compliance with regulatory requirementsProvides regulatory support for and appropriate follow-up to inspections, audits, litigation support and product complaints (depending on level of regulatory knowledge/expertise);Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance and requirements related to those areas. Experience: Bachelor's Degree is required1-2 years of related Experience