MAHALAXMI MALLAMPALLI

Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet company needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.

Regulatory Strategy: 

Defined and built regulatory strategy for medicinal product submissions and regulatory assessment of medical devices. 

Worked on various Geo-expansion projects and technology transfer submissions which includes around 24 changes. 

Prepared the strategy to submit all the variations in three waves to get faster and received acceptance form AIFA (Italy HA) for all changes within shorter duration without any queries., 

For a Geo-expansion project, worked on strategy to group all the consequential and non-consequential variations (around 36 changes) i.e. typical formulation change and got acceptance for the proposal in majority of EU countries and received approval without any queries in most of the countries., Have experience in handling various API supplier addition projects and successfully received approval globally. 

Guided colleague for a typical technology transfer dossier for an audit dossier for Malaysia and Philippines and various other geo-expansion projects.

Complied, reviewed and submitted new dossiers of solid orals, injectables for EU, APAC, ANZ, Africa, GCC., 

Worked on Product life cycle management of generic, globally managed products and have experience in assessing OTC monograph products, solid orals, injectables, medical devices (nasal aspirators, nasal spray).

Worked remediation projects for medicine and food supplement for global submissions (EU, Africa, APAC) and OTC monograph/DIN products for US and Canada along with sNDA and sNDS for US and Canada., Worked change event assessment, new SKU launch RSD for Medical devices, periodic update, pre-audit preparation etc as per MDR/MDD guidance's., Worked on various Health Authority queries and responded in timely manner with quality inputs, with an aim to avoid further queries on first round of responses.

Veeva SME (subject matter expect) to guide and provide inputs for SOPs/WI to ensure smooth flow of work and business representative for Veeva interface., Reviewed change controls and assessed their impact globally. Prepared conformance files in-line with site practices and registered information., Active member of cultural team, which organizes monthly Friday fun events for employee engagement., CMC-PLM net work forum member

• Regulatory affairs certification – RAPS