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    Lifescience Regulatory Svs Analyst

    Accenture
    3-5 years
    Not Disclosed
    Bengaluru
    10 Dec. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/M.Pharm 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: LifeScience Regulatory Services Analyst

    Location: Multiple Locations
    Company: Accenture

    About Accenture:

    Accenture is a global leader in professional services, specializing in digital, cloud, and security. With a team of over 699,000 professionals, Accenture serves clients in more than 120 countries, helping them transform and achieve sustainable success. We combine unmatched experience with specialized skills across more than 40 industries, creating value through technology and human ingenuity.

    For more information, visit www.accenture.com.

    Role Overview:

    As a LifeScience Regulatory Services Analyst, you will be part of Accenture’s Life Sciences R&D vertical. You will work on regulatory operations tasks, ensuring timely and accurate regulatory submissions across multiple global health authorities. This role involves managing submission components like bookmarking and hyperlinking, performing document quality control (QC), and transforming source documents to meet regulatory standards.

    Key Responsibilities:

    • Regulatory Operations Tasks: Bookmarking and hyperlinking submission documents as per ICH and other health authority guidelines.
    • Document Quality Control: Performing QC checks for all submission components to ensure accuracy and compliance with regulatory requirements.
    • Global Submissions: Coordinating and managing electronic submissions for original applications, amendments, CMC (Chemistry, Manufacturing, and Control), advertising promotions, annual reports, and SPL submissions.
    • Document Transformation: Review and transformation of source documents to meet the format required by regulatory agencies.
    • Collaboration: Work closely with internal teams at Accenture and peers to complete regulatory tasks. Update supervisors on progress and report any issues.

    Qualifications:

    • Educational Background:
      • Bachelor of Pharmacy or Master of Pharmacy.
    • Experience:
      • 3 to 5 years of experience in regulatory operations or related areas.
    • Skills:
      • Ability to quickly learn and adapt to new regulatory processes.
      • Strong problem-solving skills and attention to detail.
      • Ability to perform under pressure, ensuring timely submissions.
      • Excellent teamwork skills and the ability to collaborate effectively across teams.

    What We Are Looking For:

    • Learning Agility: Ability to quickly adapt and understand new processes and technologies.
    • Problem-Solving: Strong analytical skills to solve lower-complexity regulatory challenges.
    • Quality Commitment: A focus on delivering high-quality work with attention to detail.
    • Teamwork: Ability to work well within a team and contribute to collective success.
    • Flexibility: Willingness to work in rotational shifts as required.

    Why Accenture?

    At Accenture, you will be part of a global team working on cutting-edge regulatory operations for leading biopharma companies. Your work will help improve outcomes by converging scientific expertise with patient insights, ensuring that life-saving drugs and treatments reach patients efficiently.

    What We Offer:

    • Career Development: Opportunities to grow and advance in the regulatory operations and life sciences sectors.
    • Collaborative Environment: Work with a team of dedicated professionals and gain exposure to global clients.
    • Impactful Work: Contribute to the timely submission of critical health-related products, improving patient outcomes worldwide.
    • Compensation & Benefits: Competitive salary, health benefits, and incentives.

    How to Apply:

    Ready to make a difference? Apply now at Accenture Careers.

    Equal Opportunity Employer:

    Accenture is an equal opportunity employer committed to diversity and inclusion. We value diverse perspectives and create a workplace where everyone can thrive. For more information, visit Accenture EEO.

    Compensation & Benefits:

    • Salary: Competitive based on experience.
    • Incentives: Performance-based bonuses.
    • Benefits: Health insurance, wellness programs, paid leave, and more.

    Join Accenture today and help shape the future of life sciences regulatory services!

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