LifeScience Regulatory Svs Analyst

Skill required: Regulatory Services - Life Sciences Regulatory Affairs


Designation: LifeScience Regulatory Svs Analyst


Qualifications:Bachelor of Pharmacy/Master of Pharmacy


Years of Experience:3 to 5 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 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?

The candidate should possess Regulatory Affairs knowledge. Able to handle pressure and tight deadlines. He/She should possess problem solving skills, negotiate with client.

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

Qualifications
Bachelor of Pharmacy,Master of Pharmacy