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    Regulatory Affairs Specialist

    Katalyst Healthcares & Life Sciences
    7-10 years
    Not Disclosed
    Plainsboro South Plainfield
    12 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company Information:

    Company: Katalyst Healthcares & Life Sciences

    Client: Celgene

    Employer: US Tech Solutions

    Location: South Plainfield, NJ

    Employment Type: Contract

    Duration: 12 months

    Company Description:

    Katalyst Healthcares & Life Sciences hires entry-level candidates for various positions in clinical trials of drugs, biologics, and medical devices. We have immediate job opportunities in Drug Safety and Pharmacovigilance and Clinical Research fields. Our clients include university hospitals, pharmaceutical companies, and recruiting partners.

    Job Description:

    Position ID: 5175

    Department: Regulatory Affairs

    Title: Regulatory-CMC Consultant - Biologics

    Prerequisites:

    • Education: BS/BA degree in a Scientific Discipline (Masters or higher preferred).
    • Experience: Minimum of 7 years in the pharmaceutical industry, with at least 5 years in CMC regulatory (biologics preferred).

    Responsibilities:

    • Regulatory Strategy Development:
      • Develop CMC regulatory strategies for submissions including IND/CTA/BLA, NDA, CTD, and MAA filings.
    • Document Preparation and Review:
      • Lead the preparation and review of CMC submission documents, registration dossiers, health authority briefing packages, and responses with relevant line functions.
    • Agency Interactions:
      • Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings.
      • Prepare SMEs for health authority meetings as required.
    • CMC Activity Management:
      • Manage CMC activities related to specific developmental or commercial compounds.
    • Change Control Evaluations:
      • Evaluate CMC change controls from a regulatory perspective.
    • Cross-Functional Team Representation:
      • Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.
      • Take a leadership role in CMC development/commercial teams.
    • Regulatory Knowledge Maintenance:
      • Maintain knowledge of global regulatory environments, regulations, and procedures.

    Required Skills and Knowledge:

    • CMC Regulatory Documents:
      • Experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses, and IND/CTAs).
    • Regulatory Strategy Development:
      • Experience developing CMC regulatory strategies with a focus on BLA and global biologic marketing applications.
    • Guidelines Knowledge:
      • Thorough knowledge of FDA, EMEA, and ICH guidelines.
      • Knowledge of pre- and post-approval guidelines worldwide.
    • Problem Solving:
      • Solution-oriented approach to problem-solving.
    • Drug Development Process:
      • Expertise in the biologic drug development process and post-approval activities.
    • Project Management:
      • Ability to work on complex projects and within cross-functional teams.
      • Prior supervisory or project management experience.
    • Global Regulations:
      • Experience with global CMC regulations for biological compounds.

    Additional Information:

    All information will be kept confidential according to EEO guidelines.

    Benefits: Information on benefits will be provided as per EEO guidelines.

    For more information or to apply, please contact Human Resources.

     

     

     

     

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