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Lifescience Regulatory Svs Associate

1-3 years
Not Disclosed
10 Feb. 4, 2025
Job Description
Job Type: Full Time Education: B.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

LifeScience Regulatory Services Associate

Location: Bengaluru, India
Job ID: aioc-s01563686
Job Type: Full-time

About Accenture:

Accenture is a global professional services company specializing in digital, cloud, and security. With expertise across over 40 industries, Accenture offers Strategy and Consulting, Technology and Operations services, and Accenture Song. The company serves clients in over 120 countries, delivering on the promise of technology and human ingenuity.

About the Role:

As a LifeScience Regulatory Services Associate, you will support regulatory operations for the Life Sciences R&D vertical, helping global biopharma companies navigate regulatory processes and improve patient outcomes. Your role will focus on regulatory document management, quality control, and electronic submissions.

Key Responsibilities:

  • Perform regulatory operations tasks such as bookmarking, hyper linking, and transforming source documents for submission, in alignment with ICH guidelines and other Health Authorities.

  • Conduct quality control (QC) checks on submission components.

  • Coordinate documentation and resources for global application filings.

  • Manage and process electronic submissions, including original filings, Life Cycle Management submissions (CMC, Ad-promos, amendments, annual reports, SPL submissions), etc.

Skills and Competencies:

  • Quick Learning: Ability to grasp new concepts and adapt quickly to changes.

  • Deadline-Oriented: Capable of meeting deadlines under pressure.

  • Multitasking: Efficient in managing multiple tasks and stakeholders.

  • Problem Solving: Ability to solve routine problems using established guidelines.

  • Communication: Clear communication with team members and supervisors.

Qualifications:

  • Education: Bachelor of Pharmacy.

  • Experience: 1 to 3 years in regulatory operations or a similar field.

Additional Information:

This role may require working in rotational shifts. You will be an individual contributor within a team, focusing on a well-defined scope of work.