Associate Ii
2 weeks ago
A tender or contract is an agreement between the company and an external partner to provide a product at a certain quality, volume and/or price for an agreed upon timeframe. Different organizations such as government agencies, hospitals, insurance companies, etc. are increasingly pursuing tenders to manage cost
- All human health products (small molecule and Biosimilars, except Consumer products) in all markets are considered, including tender bids from government agencies, hospitals, philanthropic organizations, etc.
- Manages day-to-day regulatory activities, within agreed upon timelines.
- Evaluate tender request for completeness, accuracy and required supporting documents and communicate back to requesters for completeness of tender request
- Once a tender bid support request is received in MDRF, check PEARL (Product Events and Registration Licenses) to determine if that product has been registered in that market. Also cross verify with the details in PDM to ascertain the registration status of the product
- Knowledge in CTD documents is very essential. All CMC, Module 3 documents including CMC ancillaries are in scope of support provided by the Tender Support Team (TST)
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, as appropriate.
- Must be extremely organized as Tender requests mostly come on short notice and colleagues are expected to have excellent time management skills
- Ensures compliance to Pfizer internal procedures and training SOPs
- Should be change agile, Attention to detail and accuracy required.
- Should able to work under less supervision of line management
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
LI-PFE
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