FDA resumes in Toronto, ON, Canada

Toronto, ON, Canada
... Skills • Excellent working knowledge with HC, FDA, ICH for CTA, NDS, ANDAs,DIN, SNDS, BLA, supplements/ amendments. • Clinical Research Knowledge on Part C Div 5 of the Food and Drug Regulations, ICH E6 (R2) and ICH E8, CTA filing, GCP, GLP for ... - 2019 Oct 07

Brampton, ON, Canada
... Identified as a Subject Expert Matter (SME), and back up, providing subject matter expertise for kaizens, FDA audits, and internal regulatory inspections. Managed multiple projects with consistent attainment of on-time, on-budget, and on-scope ... - 2019 Aug 06

Toronto, ON, Canada
... Led $2.5M R&D project for a patented respiratory project involving new formulation, supervised international trademark and patent registrations Managed design and construction of $3M new head office and FDA / TPD approved distribution centre; ... - 2019 Aug 02

Mississauga, ON, L5W 1H4, Canada
... documentation on time Trained and evaluated personnel on all SOPs through quality and safety standards (SHE, TPM, FDA and all Canadian regulations as per manufacturing sector) Responsible for payroll reporting of direct and indirect labour ... - 2019 Aug 02

Toronto, ON, Canada
... Ltd Reported adverse events to FDA according to ICH guidelines related to (post-marketed) litigation drugs/vaccines. Managed timely case processing to ensure PSUR deadlines. Managed the initial assessment and distribution of adverse event triage ... - 2019 Apr 27

Etobicoke, ON, Canada
... Leading a team of 40 employees for various operation, Maintenance and project activities Faced of the Regulated audit US FDA, UK MHRA, EDQM for approval. Employment Summary Human Biologicals Institute – Indian Immunologicals Ltd Ooty Since April ... - 2019 Mar 01

Mississauga, ON, Canada
... Negotiated with senior censorship representative from the FDA and gained approvals for storyboard and paper work on a timely basis Rainbow Shanokyapa Kanapan 647-***-**** ac8kty@r.postjobfree.com Managed, delivered TV commercial tape to T.V. ... - 2019 Feb 22

Toronto, ON, Canada
... Proficient in GVP, ICH GCP, MHRA, Canadian Food and Drugs Act, and US FDA guidelines. Experience in safety database management and Adverse Event/Serious Adverse Event coding with MedDRA and drug coding with WHODD. Proficiency in narrative writing by ... - 2019 Feb 06

Thornhill, ON, Canada
... diploma in Clinical Research, Drug Safety and Pharmacovigilance, 2016-2017, Canada Practical knowledge of ICH-GCP guidelines, FDA regulations and standards governing clinical research Comprehensive understanding of Phases I-IV clinical research, ... - 2019 Feb 05

Toronto, ON, Canada
... Well-versed with ICH-GCP guidelines, GVP, FDA, CIOMS, SOP's, audits/inspections and regulatory requirements. Case processing: Solicited and unsolicited Serious and Non Serious cases. Processed approx. 3000 plus case with more focus and expertise on ... - 2019 Jan 08