LifeScience Regulatory Svs Sr Analyst

Skill required: Regulatory Operations - Life Sciences Regulatory Operations


Designation: LifeScience Regulatory Svs Sr Analyst


Qualifications:Bachelor of Pharmacy


Years of Experience:5 to 8 years


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?

Commitment to quality

Ability to work well in a team

Agility for quick learning

Problem-solving skills

Ability to perform under pressure

Roles and Responsibilities:

In this role you are required to do analysis and solving of increasingly complex problems

Your day to day interactions are 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 instruction on new assignments

Decisions that are made by you impact your own work and may impact the work of others

In this role you would be an individual contributor and/or oversee a small work effort and/or team

Please note that this role may require you to work in rotational shifts


Qualifications
Bachelor of Pharmacy