Job Details

  • Title: Regulatory Scientist
  • Code: RCI-JSN-52965
  • Location: Raritan New Jersey (NJ) 08869
  • Posted Date: 09/11/2019
  • Duration: 12 Months
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  Job Description

Description:

Bring Your Own Device (BYOD) Yes

The Regulatory Scientist provides support to the Regional Strategic Implementation Leader (RSIL) and Regulatory Regional Leader (RRL) for regulatory activities for products in the assigned portfolio.

Key responsibilities include the following:
Input in development, post-approval and life cycle management
Participates in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/global strategy.
Advises the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
Develops an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

Interaction with the Regional groups and Local Operating Companies
Works with the regional staff and LOCs to support regional and local activities;
Assists in the preparation of meetings with Regulatory Agencies.

Input in document and process development
Assists in the development of processes related to regulatory submissions;
Drafts and reviews document content (depending on level of regulatory knowledge/expertise);
Provides input to documentation to ensure they are in line with product strategy and thoroughly and accurately answers the questions being posed;
Tracks dates of submissions and Regulatory Agency responses.

Clinical Trial Applications (CTA)
Advises team on required documents in preparation of CTAs;
Provides operational support for the assembly and distribution of submissions ( e.g., Clinical trial applications for China, Health Authority Responses);
Ensures CTA submission packages are complete and available according to agreed timelines.

Marketing Authorization Applications
Provides 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 assigned;
Assists with timely registration dossier availability, ensures that all document components are in place on time, identifies and tracks critical path activities;
Compiles Module 1 for iCTDs to be dispatched to countries;
Manages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.

General
Responsible for the critical review of submission documents to ensure compliance with regulatory requirements;
Provides regulatory support for and appropriate follow-up to inspections, audits, litigation support and product complaints (depending on level of regulatory knowledge/expertise);
Serves as the Regulatory representative on specific multi-discipline teams;
Keeps abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidance and requirements related to those areas.