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    Parexel

    Clinical Research

    Senior Regulatory Affairs Associate

    India-Bengaluru-Remote, IndiaFull-time5+ yrs experiencePosted 3w ago
    All Parexel jobs

    Job description

    When our values align, there's no limit to what we can achieve.
    At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

    Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

    Job Summary:

    The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.

    Key Responsibilities:

    • Lead end-to-end CTA project management across multiple studies and countries
    • Plan, track, and deliver submissions aligned with timelines and regulatory requirements
    • Manage risks, dependencies, and complexities in global regulatory environments
    • Apply knowledge of EU CTR and ROW CTA requirements
    • Manage core clinical and regulatory documentation
    • Collaborate with cross-functional global teams
    • Build and maintain stakeholder relationships and resolve conflicts
    • Monitor KPIs related to timelines and deliverable quality
    • Identify risks and lead quality investigations as needed

    Qualifications & Experience:

    • Bachelor’s degree in Life Sciences, Pharmacy, or related field
    • Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
    • Experience in Clinical Trial Application submissions (EU CTR & ROW)
    • Strong project management experience in a global/matrix environment
    • Familiarity with clinical trials and regulatory processes

    Key Skills:

    • Project Management & Execution
    • Regulatory Knowledge (EU CTR & Global Submissions)
    • Risk & Issue Management
    • Stakeholder Engagement
    • Strong communication and problem-solving skills
    • Adaptability, resilience, and teamwork

    Job details are sourced from the employer's original posting.

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    About the company

    Parexel

    Parexel is a company focused on improving the world's health through clinical trials, regulatory, consulting, and market access solutions.

    View all Parexel jobs
    Industry
    Clinical Research
    Open roles
    198

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