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Lifescience Regulatory Svs Analyst

3-5 years
Not Disclosed
10 Dec. 26, 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: Accenture - Global Operations


About Accenture:
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. We provide Strategy and Consulting, Technology and Operations services, and Accenture Song, all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Serving clients across more than 120 countries, we aim to create value and shared success for our clients, people, shareholders, and communities. Learn more at Accenture Careers.


Role Overview:
As a LifeScience Regulatory Services Analyst at Accenture, you will be part of the Life Sciences R&D vertical, specifically focusing on Regulatory Operations. You will work with regulatory submission processes, ensuring compliance with ICH guidelines and other Health Authorities. Your primary tasks will involve bookmarking, hyperlinking, Document QC, and ensuring the accurate processing of electronic submissions for global regulatory filings, including CMC, amendments, SPL submissions, and more.


Key Responsibilities:

  • Regulatory Operations and Submissions:

    • Bookmarking and hyperlinking submission components per ICH guidelines and relevant Health Authorities.
    • Review and transform Source Documents for regulatory submissions.
    • Perform Document QC checks for all submission components.
    • Coordinate essential documentation and resources for global regulatory filings, including Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, and SPL submissions.
    • Understand and manage electronic submissions and their processing requirements.
  • Problem Solving and Analysis:

    • Analyze and resolve lower-complexity problems related to regulatory submissions.
    • Work with peers to troubleshoot issues, providing updates to supervisors as necessary.
    • Ability to perform under pressure and deliver quality results on time.
  • Collaboration and Coordination:

    • Interact primarily with peers within Accenture and update supervisors on the progress of tasks.
    • Function as an individual contributor within a team, maintaining a focused scope of work.
  • Shift Work:

    • This role may require working in rotational shifts to accommodate global operations.

Qualifications and Experience:

  • Educational Background:

    • Bachelor of Pharmacy or Master of Pharmacy.
  • Experience:

    • 3 to 5 years of experience in Regulatory Operations within the Life Sciences sector.
    • Knowledge of regulatory submission processes, including electronic submissions, Document QC, and Life Cycle Management submissions.
  • Skills:

    • Problem-solving and analytical skills.
    • Ability to handle tasks under pressure and prioritize work efficiently.
    • Strong written and verbal communication skills.
    • Agility for quick learning and adaptability to new processes.
    • Ability to work well both individually and as part of a team.

Why Accenture?

  • Work with a global leader in the Life Sciences and R&D sector.
  • Contribute to regulatory submission processes for biopharma companies.
  • Enjoy career development opportunities and a learning-focused environment.

Equal Opportunity Employment:
Accenture is an equal opportunity employer, and we are committed to fostering an inclusive environment that values diversity. We offer equal employment opportunities to all employees, including veterans and candidates with disabilities.


Apply Now and join us in delivering innovative regulatory solutions for biopharma companies at Accenture!