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    Regulatory Scientist

    Katalyst Healthcares & Life Sciences
    1+ years
    Not Disclosed
    Dunellen
    10 Nov. 22, 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, 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

    Company Description

    Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in contract research focused on clinical trials for drugs, biologics, and medical devices. We are offering exciting job opportunities in Drug Safety, Pharmacovigilance, and Clinical Research, collaborating with university hospitals, pharmaceutical companies, and recruiting partners.

    Job Description

    Position: Regulatory Scientist

    As a Regulatory Scientist, you will play a key role in providing regulatory support throughout the lifecycle of clinical trials and product registration. You will assist in regulatory submissions, advise the team on regulatory requirements, and ensure compliance with applicable guidelines.

    Responsibilities

    • Participate in global regulatory team meetings and advise on regulatory requirements and project-specific issues.
    • Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic areas.
    • Act as a back-up contact for regulatory agencies when needed.
    • Draft cover letters for regulatory communications and assist in preparation for meetings with regulatory agencies.
    • Liaise with LOCs (Local Operating Companies) to ensure timely responses to regulatory queries and maintain consistent content with the regulatory strategy.
    • Assist in process development and improvements related to regulatory submissions.
    • Review clinical trial plans and protocols to ensure alignment with regulatory requirements.
    • Provide regulatory support throughout the registration process and life-cycle management.
    • Advise on required documents and submission strategies, collaborating with LOCs as appropriate.
    • Ensure timely availability of submission documents, ensuring that all components are in place on time.
    • Draft and review documents related to regulatory submissions and compliance.
    • Assist in submission and acceptance of submission packages and ensure availability of country-specific submission packages for LOCs.
    • Provide regulatory input for inspections, audits, litigation support, and product complaints.
    • Stay updated on current and pending approvals in specific therapeutic areas and remain knowledgeable of related laws, guidances, and requirements.

    Requirements

    • An advanced degree (MS, Pharm D, PhD) is preferred; a minimum of a Bachelor’s Degree is required.
    • 1+ year of relevant experience with an advanced degree OR 4+ years with a Bachelor’s Degree is required.
    • Pharmaceutical industry experience is preferred, with a good understanding of the drug development process.
    • Knowledge of regulatory submission and approval processes, especially in the US regulatory environment, is required.
    • Direct experience in regulatory affairs is desirable.
    • Strong project management, oral & written communication, organization, and multi-tasking skills.

    Additional Information

    All your information will be kept confidential according to EEO guidelines.

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