Skill required: Regulatory Services - Life Sciences Regulatory Services
Years of Experience:1 - 3 Years
Language - Ability:English - Elementary
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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 worldâ€™s leading biopharma companies bring their vision to life â€“ 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? •Adaptable and flexible
•Ability to perform under pressure
•Ability to establish strong client relationship
•Ability to work well in a team
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