Lifescience Regulatory Svs Analyst

3-5 years

Not Disclosed

Bengaluru

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 serve clients across more than 40 industries, combining unmatched experience and specialized skills. 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. With 699,000 people worldwide, we deliver on the promise of technology and human ingenuity every day, creating value 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. You will work on a variety of tasks within Regulatory Operations, including managing electronic submissions, performing quality control (QC) checks, and ensuring compliance with ICH guidelines and other Health Authorities. This role supports the global regulatory filing process for leading biopharma companies, focusing on lifecycle management submissions such as CMC, amendments, annual reports, and more.

Key Responsibilities:

Regulatory Operations and Submissions:
- Perform bookmarking and hyperlinking for granular components (documents) of submission in accordance with ICH guidelines and relevant Health Authorities.
- Review and transform Source Documents for inclusion in regulatory filings.
- Conduct Document QC checks on all submission components to ensure compliance with regulatory requirements and standards.
- Coordinate essential documentation and resources required for global regulatory filings, including original application filings and Life Cycle Management submissions (e.g., CMC, Ad-promos, amendments, SPL submissions, etc.).
- Understand and manage electronic submissions, ensuring the accurate processing and filing of all relevant documents.
Problem Solving and Analysis:
- Handle the analysis and resolution of lower-complexity problems related to regulatory submissions.
- Work with peers to solve problems, providing updates to supervisors as needed.
- Ability to perform well under pressure and deliver quality results on time.
Collaboration and Coordination:
- Interact regularly with peers within Accenture to ensure seamless collaboration on project tasks.
- Contribute as an individual contributor within a team with a focused scope of work.
Shift Work:
- This role may require you to work in rotational shifts to accommodate global operational needs.

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.
- Familiarity with electronic submissions, regulatory requirements, and documentation standards.
- Experience with document QC, Life Cycle Management submissions, and Source Document transformation.
Skills:
- Strong problem-solving and analytical skills.
- Ability to manage multiple tasks and perform under pressure.
- Agile and quick learning abilities.
- Strong teamwork and collaboration skills.
- Attention to detail and commitment to quality.

Why Accenture?

Join a global leader in the Life Sciences and R&D industry.
Be part of a dynamic team that supports the regulatory submission and lifecycle management needs of biopharma companies.
Take advantage of career development opportunities and a learning environment focused on innovation.

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

Apply Now to be part of a team that drives innovation and excellence in Regulatory Operations at Accenture!

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Lifescience Regulatory Svs Analyst

Job Description

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