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    Senior Regulatory Start Up Associate

    Novotech
    3-5 years
    Not Disclosed
    India
    10 Sept. 10, 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

    Position Title: Senior Regulatory Start-Up Associate

    Position Overview: The Senior Regulatory Start-Up Associate is responsible for managing and overseeing the planning, preparation, and review of country and site-level ethics and regulatory submissions during the project start-up phase. This role ensures compliance with ICH-GCP standards and local regulatory requirements to secure timely approvals for clinical trials.

    Minimum Qualifications & Experience:

    • Bachelor’s degree in Clinical, Pharmacy, Life Sciences, or a related field.
    • 3-5 years of relevant experience in a CRO, pharmaceutical, or clinical/hospital setting.

    Key Responsibilities:

    • Serve as the primary contact for the Regulatory Start-Up Manager (RSM) and Project Manager (PM) during start-up on assigned projects.
    • Provide expert guidance to RSMs and PMs regarding country-specific regulations and practices, staying updated on changes affecting clinical trial approvals.
    • Work within project-specific Regulatory Start-Up plans, applicable SOPs, and ICH-GCP guidelines.
    • Provide critical timelines and submission deadlines for Regulatory Authorities, Ethics Committees, Investigational Review Boards, and other local entities.
    • Manage submission and approval timelines, ensuring updates are accurately reflected in systems, including actual and planned dates.
    • Liaise with investigative sites for interactions with regulatory and ethics authorities as required.
    • Prepare and submit regulatory applications for Central EC/IRB, local EC/Governance, and other relevant local bodies.
    • Ensure submission packages meet all local requirements and are complete and accurate.
    • Address and resolve comments or questions from regulatory bodies, providing responses after Client approval.
    • Track the progress from submission to approval and ensure timely follow-up.
    • Prepare amendments, notifications, safety reports, and other documentation required by Regulatory Authorities and Ethics Committees.
    • Escalate issues or delays to the RSM and/or PM, providing rationale and contingency plans to mitigate impacts.
    • Customize country and site-specific Informed Consent Forms (ICF) to meet local requirements.
    • Oversee translation processes for submission documents and review translations before submission.
    • Review and approve clinical trial material packaging and labeling.
    • Manage import/export license applications and oversee the clearance of licensed materials.
    • Register clinical trials in official registries as required by the Client and maintain updated statuses.
    • Submit regulatory and ethics documents to the trial master file, ensuring accuracy and completeness.
    • Perform independent reviews of essential documents and second reviews of Activation Forms for IP release.
    • May serve as a Country Lead on projects without an assigned RSM.

    Additional Responsibilities:

    • Develop master and country-specific ICFs, study-specific forms, and other necessary documents for regulatory and ethics submissions.
    • Contribute to company initiatives aimed at improving start-up processes, tools, and SOPs, making recommendations for efficiency improvements.
    • Assist in the development and delivery of Regulatory Start-Up Associate (RSA) training in partnership with the Learning and Development Manager and mentor junior RSAs.
    • Serve as a subject matter expert in specialized regulatory and start-up activities.

    About Novotech: Novotech is a leading Asia-Pacific biotech-specialist CRO, providing clinical development services across all trial phases and therapeutic areas. With ISO 27001 and ISO 9001 certifications, Novotech ensures the highest quality standards in IT security and clinical operations. Novotech operates in 11 geographies with key partnerships in medical institutions and has managed over 3,700 clinical trials, offering full-scale services from feasibility assessments to regulatory submissions and trial management.

    Join the Team: Novotech offers an opportunity to work with a dedicated team of experts in clinical research, contributing to cutting-edge developments in biotechnology. With offices across Asia-Pacific, the U.S., and the UK, Novotech is well-positioned to support global clinical trials.

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