Skill required: Regulatory Operations 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 699000 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
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 subofferings Clinical Pharmacovigilance & Regulatory helping the world’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. You will be expected to 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 Adpromos amendments annual reports SPL submissions etc.
What are we looking for
Agility for quick learning
Ability to meet deadlines
Ability to perform under pressure
Ability to manage multiple stakeholders
Ability to handle disputes 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
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