Regulatory Affairs Expert with background delivering regulatory support for pharmaceutical products and medical devices. Dedicated to collecting scientific data, interacting with clients and regulatory authorities and evaluating organizational practices to drive changes. Deep knowledge of pharmaceutical products and medical device regulatory requirements.
Proficient in TJC, OSHA, and FDA requirements for medical laboratory work. Effective at working as generalist to conduct all types of tests. Quality-focused and collaborative team player with reputation for accuracy and efficiency.
Knowledgeable about pharmaceutical products and medical device manufacturing practices, approval processes and regulations. Attentive and exacting with demonstrated success in handling domestic and international regulatory needs for diverse products. Systematic and practical with sound judgment, an analytical mindset and good problem-solving skills.
Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current uClairerstanding of legal regulations in order to keep all products compliant. Bringing 2 years of pharmaceutical product and medical device regulatory knowledge, experience, and seeking a growth-oriented position.
Skills
Project management of pharmaceutical product life cycle
Specimen tracking
Bioinformatics
Techniques in Biotechnology
Global Business in Biotechnology
Preclinical and Clinical Research
Product Life Cycle
Regulation of Pharmaceuticals and Medical Devices
FDA Compliance
Practical Application of Biotechnology in Pharmaceutical and Medical Device Manufacturing and Regulations
Bio Practicals and Business in Biotechnology
Ethical and Societal Issues in Biotechnology Application
FDA Regulations and the Food, Drug, and Cosmetic (FD&C) Act
Laboratory experiments and investigations
Scientific programs
Life sciences
Computer skills
Sterilization techniques
Specimen analysis
Equipment testing and calibration
Experimental design
In-vitro transcription
Expert in data analysis
Western blotting
Microbiological techniques
DNA isolation expert
SOP development
Strategic planning
Agency inspection support
Project planning
Technical guidance
Labeling requirements
Aseptic techniques
Quality assurance and Quality control
PPE use
Training & Development
Inspections and audits
Product inspections
Laboratory computer systems
Sampling procedures
Education and Training
University Of Maryland Global CampusAdelphi, MD, Expected in 12/2020 ā āMaster of Science:Biotechnology And Regulatory Affairs - GPA:
3.70 / 4.0 GPA
Thesis: FDA and EMA Approval process of Zimbiotic and TRACE Combination product for the Treatment of Breast Cancer. Zimbiotic and TRACE were Hypothetical Products
Completed professional development in Regulatory Affairs
Specialization in Regulatory Affairs with FDA, EMA, Health Canada, MHLW and PMDA Regulations of Pharmaceutical products and Medical Devices
Korea Nazarene UniversityCheonan, South Korea, Expected in 02/2016 ā āMaster in Education:Teaching - GPA:
4.0 / 4.5 GPA
Thesis: Educational Assessment Techniques
Dean's List Honoree Summer and Fall Semester, 2015.
Major in Education
Completed professional development in Teaching and Assessment Techniques
University Of BueaBuea, Cameroon, Expected in 11/2011 ā āBachelor of Science:Microbiology And Parasitology - GPA:
3.0 / 4.0 GPA
Honor Roll ( Second Class Upper Division)
Thesis: Microbial Contamination of drinking water in Buea
Minor in Medical Laboratory Technology
Experience
Peoria Unified School District - High School Biology Teacher Peoria, AZ, 08/2019 - Current
Evaluated submitted assignments for clarity and skills, assigned grades and discussed results with struggling students to enhance uClairerstanding of course objectives.
Explored different avenues of learning with students to help each prepare for later educational environments.
Assessed student progress with course material through routine quizzes, final examinations and standardized assessments.
Managed consistent, learning-focused classroom environments by establishing and communicating clear objectives for all students.
Adapted teaching methods and instructional strategies to promote learning in students of differing skill levels.
Explained proper lab techniques to students.
Sunrise Senior Living - Certified Nursing Medication Technician City, STATE, 11/2017 - 08/2019
Examined and addressed lacerations, contusions and physical symptoms to assess and prioritize need for further attention.
Documented information in patient charts and communicated status updates to interdisciplinary care team.
Collected biological specimens and packages for laboratory transport to complete diagnostic tests.
Obtained, recorded and reported patient vital signs as needed for medication administration.
Safely and accurately prepared all medications and sterilized products by using proper techniques, calculations and standards of precautions.
Verified patient identities using prescribed protective measures to meet facility and regulatory requirements.
Recorded observations and baseline measurements to maintain accurate medical records.
Collected, documented and reviewed patient medical histories and relayed important factors to supervising clinicians.
Accurate and Timely administration of patients' Medication
Shift supervising and reporting to Coordinator, Nurse director, and Executive director of Assisted living
Mount Zion Clinic - Medical Microbiologist and Laboratory Technician City, STATE, 11/2011 - 03/2013
Collected, labeled and stored lab samples according to laboratory specifications.
Enforced infection control and sharps disposal procedures to protect patients, co-workers and self.
Adhered to all laboratory requirements and enforced compliance with regulations.
Audited specimen integrity and identification.
Isolated, identified and prepared specimens for examination.
Analyzed experimental data and interpreted results to draft reports of findings.
Recorded, reported and posted specimen results in company software.
Cleaned and sterilized lab area, tools and equipment.
Maintained detailed logs of all experiments and relevant data and updated databases with new information.
Followed laboratory guidelines for handling biological specimens.
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