LifeScience Regulatory Svs Associate

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 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 at www.accenture.com Equal Employment Opportunity Statement We believe that no one should be discriminated against because of their differences. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, military veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by applicable law. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities.