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    Lead Regulatory Affairs Associate - New Jersey, United States - Navitas Life Sciences

    Navitas Life Sciences
    Navitas Life Sciences New Jersey, United States

    2 weeks ago

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    Description

    Job Title: Lead Regulatory Affairs

    Work Location: US – EST, CST time zone

    Reports To: Practice Head - Regulatory

    Job Description:

    • Manage day-to-day operations using project management and planning tools
    • Provide regulatory advice on development issues and communicate with stakeholders
    • Review client programs and develop strategic plans for development
    • Ensure compliance with regulatory requirements
    • Author applications for submission
    • Collaborate on SOP's, work instructions and workflows
    • Author regulatory documents with oversight for submissions
    • Work closely with development team on regulatory strategies
    • Act as the regulatory liaison
    • Help strategize EU expansion roadmap
    • Support project management activities and manage relationships with stakeholders

    Qualifications: Graduate/Post-Graduate in life sciences

    Required Knowledge and Skills:

    • Knowledge in submissions for US Markets
    • Experience in handling Oncology Products
    • Knowledge of global submission standards and regulatory change management
    • Understanding of regulatory information management concepts
    • Excellent communication, interpersonal, presentation, and persuasive skills
    • Self-driven with minimal supervision required
    • Knowledge of technology in Regulatory domains
    • Experience in eCTD Publishing systems and related tools

    Experience: Approx. 10 years in pharma/consulting companies in Regulatory domain



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