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 hyperlinking 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?
- Ability to perform under pressure
- Problem-solving skills
Roles and Responsibilities:
- Solve routine problems, largely through precedent and referral to general guidelines.
- Interactions are expected within your own team and direct supervisor.
- Provided with detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments.
- Decisions made would impact your own work.
- Individual contributor as part of a team, with a predetermined, focused scope of work.
- This role may require working in rotational shifts.
