Skill required: Regulatory Operations - Life Sciences Regulatory Operations
Designation: LifeScience Regulatory Svs Analyst
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:3 to 5 years
Language - Ability:English - Expert
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 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, Ad-promos, amendments, annual reports, SPL submissions, etc.
What are we looking for? •Negotiation skills •Problem-solving skills •Strong analytical skills •Commitment to quality •Ability to perform under pressure •Life Sciences
Roles and Responsibilities: •In this role you are required to do analysis and solving of lower-complexity problems • Your day to day interaction is with peers within Accenture before updating supervisors • In this role you may have limited exposure with clients and/or Accenture management • You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments • The decisions you make impact your own work and may impact the work of others • You will be an individual contributor as a part of a team, with a focused scope of work • Please note that this role may require you to work in rotational shifts