Umer J. Khan Email and Phone Number
Umer J. Khan is a Senior Regulatory Affairs Associate at Intrinsik Corp. - Pharmaceuticals & Biotechnology at Intrinsik Corp. - Pharmaceuticals & Biotechnology.
Intrinsik Corp. - Pharmaceuticals & Biotechnology
View- Website:
- intrinsik.com
- Employees:
- 43
-
Senior Regulatory Affairs AssociateIntrinsik Corp. - Pharmaceuticals & Biotechnology Oct 2023 - Present -
Regulatory Affairs AssociateIntrinsik Corp. - Pharmaceuticals & Biotechnology Sep 2021 - Oct 2023 -
Regulatory Affairs & Quality Assurance AssociateRaqa Consulting Inc. Jan 2021 - Apr 2021Mississauga, Ontario, Canada• Supported the preparation of regulatory submissions to the relevant regulatory agencies concerning drugs, natural health products and medical devices (DEL, SL, DIN, NDS, etc.)• Performed Canadian product label reviews in compliance with regulations for cosmetics, human drugs, medical devices, and natural health products• Drafted and executed regulatory strategies, and created responses to regulatory agencies (Clarifax)• Monitored and tracked project timelines and regulatory records in databases• Performed reviews and risk analysis of quality-related documentation, including the review of GMP documentation for product release activities -
Quality Assurance / Quality Control AssociateLec Custom Products Aug 2019 - Aug 2020• Coordinated and led investigations of Supplier Non-conformance, Planned Deviations, Customer Complaints, and Out of Specification (OOS) investigations• Created and monitored a tracking sheet for all stability data• Prepared, reviewed, and implemented Standard Operating Procedures (SOP’s)and forms• Tested Raw Materials for viscosity, pH, specific gravity, melting point, conductivity, loss of drying (LOD), and Identification testing (as per USP) • Collaborated with Suppliers and R&D to approve new raw materials for OTC andcosmetic products• Contacted and followed up with vendors to collect missing paperwork and rawmaterial data• Maintained database of all raw material specifications and related quality systems -
Science AmbassadorRyerson University Sep 2016 - Apr 2019• Assisted in the planning of public recruitment events for the University• Presented alongside professors and colleagues to upward 500+ people• Communicated with parents and potential students at recruitment events -
Research AssistantRyerson University Apr 2017 - Sep 2017Toronto, Ontario, Canada• Synthesized organic molecules for dyes, worked on building dye-based solar cells• Communicated reports and presentations on research methodology with dataand observations from chemical reactions• Performed wet chemistry, used analytical instruments such as IR, MS, and UV-VIS• Cleaned glassware, updated inventory, and prepared samples• Used a lab notebook to log work for audit and attended weekly meetings withcollaborators to outline project goals -
EnumeratorStatistics Canada Apr 2015 - Aug 2015Toronto, Ontario, Canada• Conducted in-person and phone interviews to collect census data• Data entry into Census System• Provided support to senior staff, by performing administrative tasks as required• Assisted coworkers in the use of the Census online software
Umer J. Khan Education Details
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Pharmaceutical Regulatory Affairs & Quality Operations - Raqc -
Chemistry
Frequently Asked Questions about Umer J. Khan
What company does Umer J. Khan work for?
Umer J. Khan works for Intrinsik Corp. - Pharmaceuticals & Biotechnology
What is Umer J. Khan's role at the current company?
Umer J. Khan's current role is Senior Regulatory Affairs Associate at Intrinsik Corp. - Pharmaceuticals & Biotechnology.
What schools did Umer J. Khan attend?
Umer J. Khan attended Seneca College, Ryerson University.
Who are Umer J. Khan's colleagues?
Umer J. Khan's colleagues are Laura Troscolan, Aisha E., Mei Li Mccoy, Grace Dutra, Julia Gliwa, Sheli Gomberg, Heba Stokes (Alnaseri) Ph.d.
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