Life Science Regulatory Services Associate

Skill required: Regulatory Services - Life Sciences Regulatory Operations
Designation: LifeScience Regulatory Svs Associate
Qualifications:Bachelor of Pharmacy/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? • Bookmarking and hyperlinking PDF files in accordance with FDA guidelines and other authorities. • Bookmarking and Hyper linking submission PDF corrections. • Perform document-level review of submission PDF files. • Perform corrective action and verification for submission PDF files. • Perform initial regulatory review of documents intended for publishing. • 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 • Coordinate the essential documentation and resources required for the filing of global applications. • Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.
What are we looking for? • Primary skill - Life Sciences Regulatory Operations - P5 • Prepare, review, and quality-check regulatory submission documents, including PDF bookmarking, hyperlinking, document-level QC, corrections, and verification. Ensure submission documents are technically compliant and documents-ready in accordance with FDA, EU, CA and other applicable Health Authority guidelines.
Roles and Responsibilities: • In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. • Your expected interactions are within your own team and direct supervisor. • You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments. • The decisions that you make would impact your own work. • You will be an individual contributor as a part of a team, with a predetermined, focused scope of work. • Please note that this role may require you to work in rotational shiftsBachelor of Pharmacy,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.

Visit us atwww.accenture.com

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