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    Regulatory Affairs Manager

    Vaco
    5-10 years
    $95K/yr - $120K/yr
    Brunswick
    10 July 19, 2024
    Job Description
    Job Type: Full Time 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:

    The Manager, Regulatory Affairs will be responsible for the preparation and review of various regulatory submissions to the appropriate Regulatory Agency. This role includes regulatory submissions, initiation, review of change controls and labeling, collecting and reviewing documentation required for filing, and tracking activities for timely submission.

    Responsibilities:

    • Regulatory Submissions:

      • Prepare and review regulatory submissions to the appropriate Regulatory Agency.
      • Initiate and review change controls and labeling.
      • Collect and review documentation required for filing.
      • Track activities to ensure timely submission.

    • Team Collaboration:

      • Act as a Regulatory Affairs team member in projects and program teams.
      • Understand pertinent regulations and evaluate their impact on projects/existing products.
      • Implement sound regulatory strategies for assigned products/projects within the team.
      • Ensure regulatory compliance for the safety and efficacy part of the dossier for new products as well as life-cycle management of existing products.

    • Submission Management:

      • Prepare and review original submissions and amendments.
      • Review submission documents for accuracy and adequacy, and promptly address any questions or concerns with management.
      • Maintain and update the tracker for FDA submissions/Regulatory database.
      • Track submissions such as original, amendments, supplements, annual reports, and deficiency responses.

    • Regulatory Compliance:

      • Stay updated on the Agency's expectations based on guidance and deficiencies.
      • Apply the same logic to future submissions to avoid similar deficiencies.
      • Maintain compliance with regulations relating to generic pharmaceuticals and the generic drug approval process.

    Requirements:

    • Education:

      • Degree in Science.

    • Experience:

      • At least 5-10 years of experience in the generic pharmaceutical industry.
      • Understanding of regulations relating to generic pharmaceuticals.
      • Understanding of the generic drug approval process and associated regulations.

    Desired Skills and Experience:

    • Strong understanding of regulations relating to generic pharmaceuticals.
    • Experience in the generic drug approval process and associated regulations.
    • Excellent preparation and review skills for regulatory submissions.
    • Ability to manage and track multiple submissions and regulatory activities.
    • Strong collaboration and team participation skills.
    • Effective communication skills to address questions and concerns promptly.
    • Ability to stay updated on regulatory expectations and apply this knowledge to submissions.

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