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Regulatory Affairs Specialist

Company: LanceSoft, Inc.
Location: Raritan
Posted on: June 26, 2022

Job Description:

Sr. Regulatory Affairs Specialist

  • Regional Strategic Implementation (RSI) is part of the Regional Regulatory Affairs organization within Global Regulatory Affairs and supports regulatory activities in Asia Pacific (AP), Latin America (LA) and the Emerging Markets of EMEA.
  • The team efficiently and effectively executes regional strategies and leverages processes and resources across all regions. We are therapeutically aligned and support the full lifecycle of products in all therapeutic areas.Scope of Responsibilities:
    • The Sr. Regulatory Affairs Specialist, Regulatory Strategic Implementation (RSI) will:
    • For 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).
    • Supports local labeling updates including working with global teams to review/approve local deviations from company core labeling text. Prepare forms to capture deviations and effectively communicate deviations in meetings and by email.
    • Advises team on required documents in preparation of submissions as assigned in collaboration with RSI Lead.
    • 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 registration dossiers to be dispatched to countries. Liaises with functional area representatives to obtain country specific documents for Module 1.
    • Provide support for country specific requirements database
    • Manages and tracks the assembly of country-specific submission packages to the LOCs in accordance with agreed plans.
    • Participates in Working groups to ensure timely regional and local input into product objectives, to align regions with CDT/Global strategy.
    • Interacts with the regional teams and Local Operating Companies to support regional and local activities.
    • 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;
    • Identify and initiate on-going continuous process improvement opportunities with end users responsible for data entry and/or data consumption.
    • Advises team on required documents in preparation of Clinical Trial Applications (CTA)
    • Provides operational support for the assembly and distribution of submissions ( e.g., CTA for China, Health Authority Responses).
    • Support projects related to improved system functionality or to develop new business capabilities.
    • Responsible for the critical review of submission documents to ensure compliance with regulatory requirements.
    • 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.
    • Contributes to process improvement initiatives within and across functions. Qualifications
      • A B.A./B.S. in science/relevant health-related discipline with a minimum of 4 years of relevant experience.
      • Basic understanding of the product and registration life cycle from global regulatory affairs, local operating company or affiliates, and submission process perspectives is required.
      • Knowledge of external factors (standards, regulatory requirements) that impact Product and Lifecycle Registration is preferred.
      • Previous experience liaising with local, regional, and central regulatory users to ensure that new and ongoing regulatory requirements are reflected in the system configuration, functionality and business processes is highly preferred. Experience supporting Ex-US/Ex-EU markets (rest of world) is highly preferred.
      • Demonstrated ability in working in global project teams in a matrix environment across multiple projects is required.
      • Demonstrated ability to handle multiple projects.
      • Excellent English verbal and written communication skills.
      • Must have experience developing and maintaining strong relationships.
      • Must have strong collaboration skills in order to partner effectively across other business units

Keywords: LanceSoft, Inc., Trenton , Regulatory Affairs Specialist, Other , Raritan, New Jersey

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