Skill required: Regulatory - Regulatory Affairs
Designation: Senior Analyst
Job Location: Bengaluru
Qualifications: Bachelor of Pharmacy/Master of Pharmacy/MSc
Years of Experience: 5-8 years
About Accenture Operations
In today's business environment, growth isn't just about building value-it's fundamental to long-term business survival. So how do organizations sustain themselves? The key is a new operating model-one that's anchored around the customer and propelled by intelligence to deliver exceptional experiences across the enterprise at speed and at scale. You will deliver breakthrough business outcomes for clients-by harnessing talent, data and intelligence to revolutionize their operating models. Operations is one of four services that make up one Accenture -the others are Strategy and Consulting, Interactive and Technology. Visit us at www.accenture.com
What would you do?
The Healthcare Operations vertical helps our clients drive breakthrough growth by combining deep healthcare delivery experience and subject matter expertise with analytics, automation, artificial intelligence and innovative talent. We help payers, providers and government agencies increase provider, member and group satisfaction, improve health outcomes and reduce costs.
You will be working as a part of the Labeling, Artwork review and Product Registrations team which is responsible for preparation & review of the data in the Regulatory database as well as ensuring Product Registrations with the local Health Authorities. In addition you will also be working with raw material Suppliers for ingredient information. You may also be required to do Case processing of customer complaints. Additionally, manage end to end Product Core and Country Labelling and its respective repository.
You will be responsible for building regulatory strategy, author submissions packages for various Health Authority (HA) across the globe, where you will help process regulatory documents meet HA standards i.e. Author CMC/Quality documents, review and support regulatory submissions, HA deficiency management, build HA dossiers and submit to Health Authorities. Look for automation opportunities in the Regulatory Domain.
What are we looking for?
We are looking for individuals who have the following skillset:
- Regulatory Affairs
- Adaptable and flexible
- Ability to perform under pressure
- Agility for quick learning
- Commitment to quality
- Ability to meet deadlines
Roles and Responsibilities
- In this role, you need to analyze and solve increasingly complex problems
- Your day to day interactions is with peers within Accenture
- You are likely to have some interaction with clients and/or Accenture management
- You will be given minimal instruction on daily work/tasks and a moderate level of instructions on new assignments
- You will need to consistently seek and provide meaningful and actionable feedback in all interactions
- You will be expected to be constantly on the lookout for ways to enhance value for your respective stakeholders/clients
- Decisions that are made by you will impact your work and may impact the work of others
- You would be an individual contributor and/or oversee a small work effort and/or team.
Please note this role may require you to work in rotational shifts.
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