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? • Life sciences regulatory activities • 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: • 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 shifts