Experience

Yukon Medical, LLC
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Regulatory Affairs & Compliance Specialist

  • Jul 2022 - Present


Freyr Inc.

• Canada
• Public Relations and Communications Services

• Regulatory Affairs Analyst

  • Oct 2018 - Jun 2022

  • Managing US FDA communications for INDs, NDAs, ANDAs and DMFs, including information requests, deficiency response and complete response letters. • Submitting controlled correspondences, pre-ANDA meeting requests, requesting pre-assigned application numbers etc. and assisting with site/facility registration with the US FDA for foreign pharmaceutical companies/facilities. • Coordinating with US FDA for communications pertaining to post-approval change submissions, such as prior approval supplements, CBE-30, CBE-0 and annual report filings, user fee payments etc. • Assisting with the regulatory process of voluntary recall of drugs and other consumer products. • Strategizing the launch of drugs, cosmetics and personal care products in multiple international markets, by determining the regulatory pathway, product classification, registration/notification requirements, dossier compilation etc. • Partnering with marketing & creative teams for approval of packaging artwork, labels & claims, and other promotional materials, ensuring their compliance with regulations. • Collaborating with internal company teams, international affiliates, and license partners to support new product registration (for drugs and personal care products) and maintain existing marketing authorizations. • Coordinating regularly with multidisciplinary internal/external teams to prepare comprehensive project plans, maintaining project timelines, identifying potential project-related risks and delays, and assisting in development and execution of strategies for their mitigation. • Establishing project scope and planning the specific key action items, deliverables, milestones, timelines, communication process and flow etc. • Participating in the company’s business processes from sales and solutioning point of view. For e.g., drafting of proposals, review of rate cards, preparation of pricing sheet, raising invoices etc. Show less



John Hopkins Bloomberg School of Public Health

• Regulatory Intern

  • Apr 2018 - Jun 2018

  • Conducted systematic review of various clinical studies following the evidence-based toxicology (EBT) methods. • Researched the guidelines for conducting & validating methods for in-vitro tests (as an alternative to animal testing) approved by Organization for Economic Co-operation & Development (OECD). • Compared the different validation regulations and processes for in-vitro tests between the regulatory agencies of US, EU, China, and Japan. • Conducted systematic review of various clinical studies following the evidence-based toxicology (EBT) methods. • Researched the guidelines for conducting & validating methods for in-vitro tests (as an alternative to animal testing) approved by Organization for Economic Co-operation & Development (OECD). • Compared the different validation regulations and processes for in-vitro tests between the regulatory agencies of US, EU, China, and Japan.



Synaptive Medical

• Canada
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Regulatory Intern

  • Apr 2017 - Jun 2017

  • Devised a strategy for registering medical devices in seven international jurisdictions - Hong Kong, Malaysia, Singapore, Japan, Israel, Thailand, and Australia. • Prepared a comprehensive regulatory intelligence report for each country consisting of information ranging from, the device classification to the post-marketing requirements. • Determined the classification category of the devices for their registration in EU. • Researched the changes in the new EU MDR legislation and its impact on the registration and lifecycle management process of new and existing devices. • Identified the regulations pertaining to the marketing of used/refurbished medical devices and their regulatory clearance. Show less



Azine Healthcare Pvt Ltd

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Intern

  • May 2015 - Jul 2015

  • Prepared quality reports for raw/finished materials and conducted approval/rejection of production batch records. • Reviewed SOPs, policies, and process documentation to understand the procedure of achieving operational efficiency for drugs. • Worked cross-functionally to analyze deviations and inspected BPCR and other quality documents for their integrity. • Conducted examination of various analytical parameters associated with QC (purity assays, visual tests and more). Show less