Skill required Regulatory Services - Life Sciences Regulatory Operations Designation LifeScience Regulatory Svs Associate Qualifications Bachelor 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 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 our Life Sciences R D vertical Our services span across the entire life sciences enterprise from research laboratories clinical trials support and regulatory services to pharmacovigilance and patient services solutions Employees under this span will be a part of one of the sub-offerings - Clinical Pharmacovigilance Regulatory helping the worldaEUR TM s leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient connecting scientific expertise with unique insights into the patient experience 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 Looking for Pharma graduates with less than an year experience with ectd publishing or document publishing Roles and Responsibilities oIn this role you are required to solve routine problems largely through precedent and referral to general guidelines o Your expected interactions are within your own team and direct supervisor o You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on recent assignments o The decisions that you make would impact your own work o You will be an individual contributor as a part of a team with a predetermined focused scope of work o Please note that this role may require you to work in rotational shifts Bachelor of Pharmacy