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    Regulatory Affairs Specialist Project Lead I (Scientific)

    Hire Talent
    8-10 years
    Not Disclosed
    Remote, USA
    10 July 4, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Description

    Job Title: USA-Regulatory Affairs Specialist Project Lead I (Scientific)
    Job Duration: 6 Months (W2 Contract)
    Job Location: Fully Remote

    Overview

    We are seeking a dedicated Regulatory Affairs Specialist Project Lead to join our team. This role involves developing and executing innovative, value-added global regulatory strategies for immunology products in early development. The ideal candidate will lead the formulation of the Global Regulatory Project Strategy (GRPS) and develop a global Health Authority (HA) interaction plan in collaboration with the Global Regulatory Team (GRT). Additionally, the role includes communicating key outcomes to senior management.

    Responsibilities

    • Lead the development and execution of global regulatory strategies.
    • Formulate the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development.
    • Develop a global HA interaction plan and strategy in collaboration with the Global Regulatory Team (GRT).
    • Communicate key outcomes and updates to senior management.

    Education and Experience

    • Required: BS/BA degree in a relevant scientific discipline.
    • Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field).
    • At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D.
    • Minimum of 5 years of relevant Regulatory Affairs experience (regionally and/or globally) in early development.

    How to Apply

    To apply for this opportunity, please send your resume to recruiter@hiretalent.com with the job number and job title in the subject line. Alternatively, you can register in our system:

    1. Click on the job title and then click one of the "Apply" buttons. You will be prompted to submit your resume directly for that role.
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    About Us

    We are a Consciously Unbiased™ organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For more information, visit Consciously Unbiased.

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