Ø  Reviewing the documents sent by the requestor via e-mail, GDMS link, or the Global Tender & Contracting

System (GTCS) database or GCMC tender support mailbox

Ø  Manages day-to-day regulatory activities, within agreed upon timelines

Ø  Evaluate tender request for completeness, accuracy and required supporting documents and communicate back to requesters for completeness of tender request

Ø  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

Ø  Ancillaries to be picked from SPA system and relevant stakeholders to be contacted within set timeline and share the documents back to requester within standard timeline

Ø  Should be vigilant on Ancillaries not crossing due dates by having continuous watch on SPA system

Ø  Few ancillaries to be handled as rush request to enhance business support

Ø  Knowledge in CTD documents is very essential. All CMC, Module 3 documents including CMC ancillaries are in scope of TAT

Ø  Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, ARS share point, as appropriate

Ø  Must be extremely organized as Tender requests mostly come on short notice and colleagues are expected to have excellent time management skills

Ø  Ensures compliance to Pfizer internal procedures and training SOPs

Ø  Should be change agile, Attention to detail and accuracy required

Anyotherrequestsasassignedbylinemanagers

  
Work Location Assignment: On Premise

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