LifeScience Regulatory Svs Sr Analyst

Accenture PLC; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Accenture PLC in Bengaluru, India, is seeking a LifeScience Regulatory Services Senior Analyst with 5–8 years of experience and a Master of Pharmacy to support regulatory writing and submission activities across CMC documents.

You will collect data, draft sections, and collaborate with teams to ensure accuracy and compliance with ICH guidelines. Knowledge of Veeva RIMS and DMS is essential, and you may work in rotational shifts depending on project needs.

Qualifications

• Experience with data collection and drafting of CMC documents.
• Knowledge of regulatory submissions and ICH guidelines.
• Proficiency in Veeva RIMS and DMS.

Responsibilities

• Analyze and solve increasingly complex regulatory problems.
• Collaborate with peers and may interact with clients or management.
• Possess ability to lead small work efforts or teams as needed.
• Be prepared for rotational shifts.
• Ensure records of CMC authoring activities align with organizational standards.

Skills

Clinical & Regulatory Writing

Regulatory submissions

ICH guidelines

Education

Master of Pharmacy

Tools

Veeva RIMS

DMS

Job description

Skill required: Regulatory Services - Clinical & Regulatory Writing
Designation: LifeScience Regulatory Svs Sr Analyst
Qualifications: Master of Pharmacy
Years of Experience: 5 to 8 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. www.accenture.com

What would you do?

• Assist with data collection and initial drafting of Chemistry, Manufacturing, and Controls (CMC) documents.
• Collaborate with team members to ensure accuracy and completeness of regulatory submissions.
• 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
• Produce variety of clinical documents throughout the lifecycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through to preparing regulatory submission documents including post approval reports.

What are we looking for?

• Primary skill - Clinical & Regulatory Writing - P5
• Maintain records of CMC authoring activities in alignment with organizational standards.
• Have understanding on Veeva RIMS and DMS

Roles and Responsibilities:

• In this role you are required to do analysis and solving of increasingly complex problems.
• Your day to day interactions are with peers within Accenture.
• You are likely to have some interaction with clients and or Accenture management.
• You will be given minimal instruction on daily work tasks and a moderate level of instruction on new assignments.
• Decisions that are made by you impact your own work and may impact the work of others.
• In this role you would be an individual contributor and or oversee a small work effort and or team.
• Please note that this role may require you to work in rotational shifts

Master of Pharmacy

About Accenture

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities.

www.accenture.com

Equal Employment Opportunity Statement

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