Regulatory Affairs – Associate | Pfizer | Chennai

Job Description

Responsibilities:

• 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.
• Documents will be sent to the requestor via e-mail, GDMS link, or the Global Tender & Contracting System (GTCS) database or GCMC tender support mailbox
• Manages day-to-day regulatory activities, within agreed-upon timelines.
• Evaluate tender requests 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 the details in PDM to ascertain the registration status of the product
• Knowledge of CTD documents is very essential. All CMC, Module 3 documents including CMC ancillaries are in the scope of support provided by the Tender Support Team (TST)
• Utilizes Pfizer’s CMC systems, i.e. GDMS, and 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 with Pfizer internal procedures and training SOPs
• Should be changed to agile, with Attention to detail and accuracy required.
• Should be able to work under less supervision of line management