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    License To Operate Lead

    Roche
    3+ years
    Not Disclosed
    China Remote Shanghai Shi
    10 Feb. 13, 2025
    Job Description
    Job Type: Remote 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

    Job Title: (Senior) Manager, Technical Regulatory

    Location: Shanghai, Shanghai, China's Mainland
    Category: Regulatory Affairs
    Job ID: 202408-121546

    Position Overview

    At Roche, we are passionate about shaping the future of healthcare through continuous innovation. We are currently seeking a (Senior) Manager, Technical Regulatory to join our dynamic team. This role is essential for coordinating and preparing regulatory submission packages for new and mature products, ensuring compliance with both local and regional registration requirements, and aligning with company policies.

    You will have the opportunity to engage with regulatory agencies, monitor and improve submission tracking systems, and drive regulatory excellence through proactive strategies. Your expertise will directly contribute to Roche’s goal of bringing life-saving products to patients in a timely manner.

    Key Responsibilities:

    • Regulatory Submissions Preparation:
      • Coordinate the preparation of high-quality CMC (Chemistry, Manufacturing, and Controls) regulatory documents for both local and global markets.
      • Ensure alignment with Roche corporate standards and applicable health authority requirements in support of local and global filings.
    • Change Control Management:
      • Oversee the regulatory aspects of change control and ensure communication to relevant stakeholders regarding technical changes.
      • Provide regulatory support for quality systems related to change control, discrepancy management, and Health Authority inspections.
    • Regulatory Agency Interaction:
      • Serve as a liaison between Roche and regulatory agencies, ensuring smooth communication on defined matters.
      • Interact with health authorities to facilitate approvals, and recommend strategies for clinical trial applications and approvals.
    • Regulatory Strategy & Risk Management:
      • Keep the Technical Regulatory Lead (TRL) and other stakeholders informed of project statuses, potential submission risks, and impacts on timelines.
      • Identify opportunities to improve processes, mitigate risks, and ensure continuous regulatory excellence.
    • Cross-functional Collaboration:
      • Collaborate with technical partners in China and across the organization to ensure alignment on regulatory strategies.
      • Support regulatory submissions for IND, NDA/BLA, and complex variations across the product lifecycle.

    Who You Are

    Qualifications:

    • Education:
      • A Master’s degree in life sciences or a related discipline is preferred.
    • Experience:
      • A minimum of 3 years of experience in the pharmaceutical, biotechnology, or related industry, focusing on CMC, Regulatory Affairs, Quality, R&D, Manufacturing, or similar fields.
      • Experience generating technical registration dossiers for China, EU, or USA markets is preferred.
      • Experience with filing and managing regulatory submissions is a plus.

    Knowledge & Skills:

    • Technical Knowledge:
      • Strong knowledge of ICH (International Council for Harmonisation), WHO (World Health Organization), and China regulations and guidelines. Familiarity with regulations from other major markets, such as the FDA and EMA, is a plus.
      • Proficiency in managing a wide range of data/information, including CMC, clinical, and non-clinical data.
    • Analytical Skills:
      • Strong problem-solving skills and the ability to assess regulatory risks, identify solutions, and drive continuous improvement.
    • Collaboration Skills:
      • Proven ability to work collaboratively with cross-functional teams and communicate effectively with both internal stakeholders and external regulatory agencies.

    Why Roche?

    At Roche, we are committed to advancing science and ensuring that everyone has access to healthcare. As a (Senior) Manager, Technical Regulatory, you will play a crucial role in bringing innovative products to market while ensuring the highest regulatory standards are met. This is a fantastic opportunity to join a global leader in healthcare and make a real impact on patients’ lives.

    How to Apply

    If you are ready to join a global team that values diversity, collaboration, and innovation, apply today for the (Senior) Manager, Technical Regulatory position at Roche. Together, we can shape the future of healthcare.

    hey need.

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