Ritika Sarkar
Toronto,ON
Summary
Strategic Regulatory Affairs Manager known for high productivity and efficient task completion. Possess specialized skills in regulatory compliance, strategic planning, and risk management. Excel in communication, problem-solving, and teamwork to navigate complex regulatory environments and ensure organizational adherence to global standards.
Overview
6
6
years of professional experience
6
6
Certification
Work History
Quality Control & Regulatory Affairs Manager
Nutrinda Food Sciences
, India
08.2020 - 08.2021
- Monitored changes in food regulations to maintain compliance at Nutrinda Food Sciences.Prepared documentation for product registrations and approvals in various markets.
- Performed quality and food testing in accordance with FSSAI (Food Safety and Standards Authority of India) and NABL (National Accreditation Board for Testing and Calibration Laboratories) standards. Coordinated with NABL-accredited food-testing laboratories for sampling, testing, and compliance, while implementing quality control procedures for processing, packaging, & storage of spices to ensure adherence to industry standards and client-specific requirements.
- Performed comprehensive research and biochemical studies, involving antibiotic formulation, organism identification, as well as efficacy assessments.and sterile laboratory operations, while independently managing laboratory equipment.
- Collaborated with cross-functional teams such as quality assurance, manufacturing, engineering, legal, marketing, and sales on projects related to regulatory affairs initiatives.
- Analyzed data from clinical studies conducted according to ICH GCP and GMP guidelines.Created and maintained regulatory databases for tracking submissions and approvals.
- Evaluated potential risks associated with new products or changes before submitting them for review by regulators.
Research Intern
All India Institute of Medical Science (AIIMS)
New Delhi, India
05.2015 - 07.2015
- Acquired hands-on experience with key clinical and laboratory techniques used in the screening, diagnosis, and treatment of cancer, including PCR, ELISA, electrophoresis, and cell viability assays.
- Conducted preclinical studies on HeLa and SELA cell lines to evaluate the cytotoxic effects of cisplatin, supporting drug efficacy and mechanistic research.
- Assisted in maintaining detailed and accurate laboratory records in alignment with institutional SOPs and ethical research standards.
- Gained exposure to Good Clinical Practice (GCP) principles and regulatory considerations in translational oncology research.
- Collaborated with multidisciplinary teams including clinicians, researchers, and lab technicians to support ongoing clinical research initiatives.
Subject Matter Expert (Biology and Healthcare)
Evelyn Learning systems
, India
09.2019 - 08.2020
- Collaborated with instructional designers to enhance course content.Provided subject matter expertise during curriculum reviews.
- Assisted in the integration of new educational technologies. Supported educators by answering course-related inquiries.
- Facilitated communication between teams to ensure project alignment.Offered one-on-one support for team members and managers to drive continuous improvement.
- Provided subject matter expertise during meetings with senior leadership team members in order to discuss potential opportunities or challenges.
- Managed multiple projects simultaneously while adhering to tight deadlines.Assessed company operations for compliance with safety standards.
- Created and managed project plans, timelines and budgets.
Account Development Representative
Biogeniux Medsystems
08.2019 - 09.2019
- Assumed responsibility for the sales cycle, with a strong focus on growing the top of the sales funnel by qualifying inbound business opportunities and generating new leads in Microsoft 365 CRM.
- Developed a deep understanding of the product value proposition and use cases by managing quality database, followed up and converted inbound leads to qualified sales opportunities for Business Development Managers.
- Worked in a team responsible for monthly quotas up to CAD $1.6M (INR 10M to 100M), targeted Sales Directors, Scientists, Researchers and C-Level executives within the biotechnology and pharmaceutical market.
- Conducted market research and gathered competitive intelligence to inform business decisions.
Education
MS - Healthcare Administration And Service Management
Conestoga College
Kitchener, ON, Canada01.2022
MSc. - Biotechnology
Guru Nanak Dev University
Amritsar, India01-2018
BSc. - Biomedical Sciences (Honors)
Delhi University
India01.2016
Skills
- Protein Bradford and BCA Assays
- Regulatory compliance
- Clinical research
- Documentation management
- Data analysis
- Project management
- Karyotyping
- Cell culture
- ELISA
- Flow cytometry
- Analytical biochemical assays
- Attention to detail
- Problem solving
- Medical device regulations
- Regulatory intelligence
- Clinical trial oversight
- Biotechnology industry
- Medical device regulations
- Clinical trial oversight
- Biotechnology industry
- Leadership skills
Certification
- Covid 19
- Virology
- Clinical Trial
- ICH-GCP
- Project Management
- Regulatory Affairs
- Cosmetic Formulation
- Phlebotomy
Projects
- PPAR-γ gene and its role in regulating Type II Diabetes, Studied the role of PPAR-γ gene in the identification and characterization of functional PPAR response element in patients with Type II Diabetes. Performed various biochemical assays and techniques like protein extraction and purification methods.
- Thesis Project on Screening and Detection of cellulolytic bacteria in various soil samples, Department of Oncology, All India Institute of Medical Science (AIIMS), New Delhi, Delhi, India, 3 Months, Dr. Lalit Kumar, Performed cell culture, protein extraction, enzyme assay, for detection, diagnosis, and treatment of cancer., Learnt about various molecular techniques and biochemical assays.
- GIAN programs, Completed GIAN (Global Initiative for Academic Networks) programs on 'Cell engineering for biomedicine – Basics to application' and 'post-transcriptional control of gene expression in Eukaryotes.'
Volunteer Experience
- Hospital Volunteer, CGHS (Central Government Health Scheme) Hospital Clinics, New Delhi, Delhi, India
- Voluntary tutor, Tutor for children with special needs, New Delhi, Delhi, India
Languages
English
Proficient (C2)
C2
French
Intermediate (B1)
B1
References
References available upon request.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Quality Control & Regulatory Affairs Manager
Nutrinda Food Sciences
08.2020 - 08.2021
Subject Matter Expert (Biology and Healthcare)
Evelyn Learning systems
09.2019 - 08.2020
Account Development Representative
Biogeniux Medsystems
08.2019 - 09.2019
Research Intern
All India Institute of Medical Science (AIIMS)
05.2015 - 07.2015
MS - Healthcare Administration And Service Management
Conestoga College
MSc. - Biotechnology
Guru Nanak Dev University
BSc. - Biomedical Sciences (Honors)
Delhi University
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