Regulatory Affairs Associate

Govinda Ramirez

** ******** ***, *******, ** Phone +1-647-***-****

*******.***@*****.***

Professional Summary

A Regulatory and Quality Pharmaceutical Industry Professional with experience of document authoring, submission compilation and dispatching global regulatory submissions compliant with Health Authority electronic requirement, extensive experience in Quality requirements and Project development. Looking for opportunities in the area of Regulatory affairs, Bio-Pharmaceutical, Pharmaceutical and Medical Devices Industry. 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 Clinical and non clinical Trials and correspondent inspections,

• Collaborative Knowledge of eCTD publishing, NDS, M1 document authoring, M2-M5 compilation.

• Experience in Regulatory Publishing using Lorenz docuBridge®, Microsoft® Office, Adobe, Adobe Acrobat Pro11, Lorenz eValidator®, Power Point, Excel

• Knowledge of Internal and external publishing standards for Canada, US and EU Submissions.

• Thorough knowledge of 21CFR Part 11, Health Canada and FDA standards for GMP, GCP, GLP. Projects

• NDS for Loratadine 10mg tablet by Lorenz docuBridge®, Lorenz eValidator®.

• Authoring Informed Consent Form,

• PLA submission for Garcinia Cambogia tablets, ePLA for Odor controlled Garlic 500mgTablets

• DEL Application, SL Application

• SOP Writing for DEL Administration and preparation

• Product Monograph Writing, Informed Consent Form authoring

• Project management: Project and Gantt Chart on Preparation of SLA

• HC/SC 3011 for NDS, Pre-CTA meeting request

Work History

Formulation Scientist - Research & Development 2012-2014 Labincos S.A de C.V

Formulation Development and production scale-up and post stability testing. Collaborative relationship with Raw material suppliers, QC, Production, and Marketing. Product Benchmarking. Compliance with Regulatory Requirement for developed Products. Quality Assurance Manager 2011-2012

Labincos S.A de C.V

Implementation of QA systems and Microbiological testing system Design with 50% test-results time reduction. Process Validation with correspondent SOPs Design. Quality Control Processes supervision. Laboratory Analyst 2010-2011

Laseclat S.A de C.V

Perform Physicochemical analysis to Water, Air, Food, Raw materials and Non organic samples in accordance with ISO/IEC 17025:2005.

GLP and Applicable Regulations, Measurements and Document traceability. Microbiology Technician 2008-2010

Microbiologia Medica Diagnostica, UANL

Media and broth preparation for microbiological testing, Sample Collection and Handling. Read plates and tubes and write interpretation report.

Education

Post-Grad Certification [Honours] : Regulatory Affairs, 2019 Toronto Institute of Pharmaceutical Technology [TIPT]. Ontario, Canada Bachelor of Science: Biopharmaceutical Chemistry, 2011 Universidad Autónoma de Nuevo Leon. Monterrey, Mexico Others

• English, Spanish, French [read]

• Excellent time, resources and organization skills

• Document review, collect and summarize scientific and technical data.

• Ability to work well within cross-functional teams.

• Multitasker, Work under time constraining environments References upon request

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