LifeScience Regulatory Svs Associate

Accenture; Bengaluru; On-site; INR 700,000 - 1,000,000; Full time

Job summary

Accenture is seeking a LifeScience Regulatory Svs Associate to support regulatory affairs activities in Bengaluru. The role involves end-to-end regulatory operations, document preparation, and ensuring compliance with ICH guidelines and health authority requirements.

A Master of Pharmacy with 1–3 years of experience is expected. The incumbent will collaborate with cross-functional teams, manage submission timelines, and contribute to global regulatory lifecycle submissions across multiple

Qualifications

• Master of Pharmacy degree required.
• 1–3 years of regulatory affairs experience.

Responsibilities

• Regulatory operations tasks including bookmarking and hyperlinking for submission components per ICH and health authorities.
• Perform QC checks on submission components.
• Collect, collate, and evaluate scientific data for R&D.
• Advise on legal and scientific requirements to ensure regulatory compliance.
• Build regulatory submission strategies and author CMC documents and health authority packages.

Skills

Life Sciences Regulatory Affairs

Education

Master of Pharmacy

Job description

Skill required: Regulatory Services - Life Sciences Regulatory Affairs

Designation: LifeScience Regulatory Svs Associate

Qualifications:Master of Pharmacy

Years of 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 and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 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?

• Regulatory Affairs scope of services
• The incumbent will perform the regulatory operations tasks of bookmarking and hyper linking for granular components documents of submission in accordance with ICH guidelines and other Health Authorities review and transform Source Documents Perform Quality Control Document QC checks for all submission components
• Collect, collate and evaluate the scientific data gathered as part of R & D.
• Advise on legal and scientific restraints and requirements.
• Ensure the organization s products comply with current regulations.
• Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc.

What are we looking for?

• Primary skill - Life Sciences Regulatory Affairs - P1

Roles and Responsibilities:

• Work on end-to-end planning, coordination, compilation, publishing, and dispatch of global regulatory lifecycle submissions across multiple health authorities.
• Ensure regulatory dossiers and submission packages comply with regional requirements, eCTD standards, and applicable regulatory guidelines.
• Manage submission timelines, lifecycle activities, renewals, variations, supplements, annual reports, and post-approval regulatory changes.
• Collaborate with cross-functional stakeholders to track submission readiness, resolve gaps, and support timely health authority interactions and responses.
• Utilize Regulatory Information Management Systems (RIMS), publishing tools, and quality review processes to deliver compliant, high-quality submissions with on-time execution Master of Pharmacy

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