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    Sr. Scientist, Regulatory Affairs - Chemistry, Manufacturing & Controls (Cmc)

    Organon
    4+ years
    Not Disclosed
    Lisbon
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: MS/MBA/Ph.D/PharmD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: Senior Scientist – Regulatory CMC

    Organization: Organon
    Employment Type: Regular
    Travel Requirements: ~10%

    Position Overview

    The Senior Scientist – Regulatory Chemistry, Manufacturing & Controls (CMC) is responsible for implementing global CMC regulatory strategies to support product compliance and lifecycle management. This includes preparing and reviewing CMC submission documentation, collaborating with internal and external stakeholders, and ensuring conformance with regulatory requirements.

    Key Responsibilities

    Strategic Contribution

    • Regulatory Strategy Development:
      • Perform assessments of CMC changes.
      • Identify global regulatory requirements and risks, incorporating them into strategic plans.
    • Project Execution:
      • Author and review CMC components for regulatory submissions, including post-approval supplements.
      • Liaise with manufacturing and supply teams to ensure accurate execution of regulatory activities.

    Compliance and Documentation

    • Lifecycle Maintenance:
      • Ensure compliance through timely updates to CMC submissions and databases.
    • Regulatory Documentation:
      • Critically evaluate technical documentation for regulatory compliance.
      • Prepare high-quality submissions in alignment with regulatory standards.

    Risk Mitigation and Communication

    • Assess and communicate potential regulatory risks.
    • Propose and implement risk mitigation strategies to ensure project success.
    • Collaborate with cross-functional teams to address issues and align on regulatory strategies.

    Required Qualifications

    Educational Background

    • Bachelor’s Degree in a scientific or engineering field (e.g., Chemistry, Biochemistry, Chemical Engineering, Biology, Pharmacy, etc.) with 4+ years of relevant experience; OR
    • Advanced Degree (MS, MBA, Ph.D., PharmD) in a related field with 2+ years of relevant experience.

    Experience

    • Minimum 2 years of CMC experience, including biological/pharmaceutical research, manufacturing, or testing.
    • Proficiency in global regulatory guidelines for CMC, post-approval change management, and data requirements.

    Skills

    • Strong written and oral communication skills, with the ability to convey complex topics succinctly.
    • Technical expertise in assessing SME documentation for regulatory compliance.
    • Knowledge of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.

    Preferred Qualifications

    • Direct experience in Regulatory CMC and/or authoring regulatory documentation.
    • Experience in regulatory activities for devices or combination products.
    • Leadership in managing multiple projects with on-time deliverables.
    • Demonstrated flexibility in adapting to dynamic priorities or unexpected challenges.

    About Organon

    Organon is a global healthcare company committed to making a meaningful impact on women's health, biosimilars, and other diverse therapeutic areas. With a focus on innovative solutions, Organon aims to create a healthier future for women and their communities.

    As an equal opportunity employer, Organon fosters a culture of inclusion and welcomes candidates from diverse backgrounds to join its mission.

    Employee Status: Regular
    Flexible Work Arrangements: Flex Time
    Relocation Assistance: Not available
    Number of Openings: 1

    Requisition ID: R530032

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