Online applications are invited for the internship at Pfizer for the year 2023. Online applications are open on the official website.
About
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer and his cousin Charles F. Erhart.
Responsibilities
- Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines.
- Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
- Performs Market Impact Assessment (MIA) for the specific entity name change.
- Runs the Regulatory Requirement Manager to determine the filing action and impacted sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
- Search Regulatory databases for Common Technical Document components or request them from appropriate market contacts, when not available.
- Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database.
- Should be familiar with submission grouping practices.
- Interpret and apply global/regional CMC regulatory policies.
- Request documents from the sites/markets/center functions as needed.
- Request Ancillary documents from Ancillary documents team.
- Communicate with markets if clarification/prioritization is needed.
- Follow up with all responsible disciplines to be able to meet timelines.
- Authoring of the impacted CMC sections i.e. Module 3 under the guidance from the CMC GRL as appropriate and within agreed timelines.
- Responsible for obtaining the approval in Reg-459 form from GRL on the completion of authoring the sections.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc., as appropriate.
- Must be extremely organized as LEC projects can run across multiple products/markets.
- Ensures compliance to Pfizer internal procedures and training SOP’s
Skills required
- Analytical Skills
- Communication
- Organization Skills
- Problem Solving
- Chemistry, Manufacturing, and Controls (CMC)
- Common Technical Document (CTD)
- LEC
- Support Services
- Timelines
- Web Authoring
How to Apply?
Interested students can directly apply through this link.
Location
Chennai, Tamil Nadu.
One Response
I am jaswanthi from msc medical bioinformatics in sri ramachandra college seeking for an internship in your company .