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Lifescience Regulatory Svs Associate

0-3 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences 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 Description

Skill Required

Regulatory Services – Life Sciences Regulatory Operations

Designation

Life Sciences Regulatory Services Associate

Qualifications

Master of Pharmacy (M.Pharm)

Experience

1 to 3 years


About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy & Consulting, Technology & Operations services, and Accenture Song—powered by the world’s largest network of Advanced Technology and Intelligent Operations centers.

Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities.
Visit us at www.accenture.com


What Would You Do?

You will be aligned with the Life Sciences R&D vertical. Our services span across the entire life sciences enterprise—covering research laboratories, clinical trial support, regulatory services, pharmacovigilance, and patient services solutions.

As part of the Clinical, Pharmacovigilance & Regulatory sub-offering, you will support leading biopharma companies by:

  • Performing regulatory operations tasks such as bookmarking and hyperlinking submission documents in line with ICH guidelines and health authority requirements.

  • Reviewing and transforming source documents.

  • Conducting quality control checks (Document QC) for submission components.

  • Coordinating essential documentation and resources for global application filings.

  • Managing and processing electronic submissions, including:

    • Original application filings

    • Life cycle management submissions (e.g., CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.)


Skills We Are Looking For

  • Strong written and verbal communication skills

  • Ability to work effectively in a team

  • Results orientation

  • Agility and quick learning capability

  • Problem-solving skills


Roles and Responsibilities

  • Solve routine problems using precedent and general guidelines.

  • Interact primarily within your team and with your direct supervisor.

  • Follow detailed to moderately detailed instructions for daily tasks and new assignments.

  • Make decisions that impact your own work output.

  • Work as an individual contributor within a team on a focused scope of work.

  • Be prepared to work in rotational shifts, if required.