Jessica Fernandes
Pearland
Summary
Recognized for exceptional contributions and unwavering dedication in submission management, earning a certificate of appreciation. Achieved academic distinction in the first year of industrial pharmacy specialization at MCOPS, Manipal, receiving an award for excellence. Honored with the prestigious Dr. TMA Pai Gold Medal for Outstanding Research for publication on amino acid conjugated chitosan nanoparticles, targeting a model dipeptidyl peptidase-4 inhibitor in the brain. Published in the International Journal of Pharmaceutics in July 2018 (547, 563-571).
Overview
8
8
years of professional experience
Work History
Senior Regulatory Affairs Specialist – Private brand products
Cardinal Health
Mansfield, MA, USA
06.2022 - Current
- Develop and implement regulatory strategies for private brand medical devices, including product classification and pathway selection
- Ensure alignment with the company’s business goals and market requirements
- Coordinated private registration processes in multiple regions including the US, Canada, EU, APAC, and LATAM.
- Monitor and maintain compliance with relevant international and regional regulations, standards, and quality management systems
- Stay up to date with changes in regulations and standards and assess their impact on product compliance
- Review and approve product labeling, instruction for use, and technical documentation to ensure they meet regulatory requirements
- Establish and maintain positive relationships with supplier
- Collaborate with R&D, quality assurance, quality control, marketing, and other departments to ensure regulatory requirements are met throughout the product lifecycle
- Address changes and updates related to products in market
- Enhanced company compliance with FDA regulations by conducting thorough internal audits and implementing corrective actions.
- Established strong rapport with external stakeholders such as suppliers, contract manufacturers, distributors for efficient communication and compliance.
- Ensured successful product launches by navigating complex regulatory requirements and obtaining necessary approvals in a timely manner.
- Reduced submission review timelines by effectively managing cross-functional teams to ensure timely completion of tasks.
- Facilitated work on technical documentation and supplier-related changes with consistent delivery within set deadlines.
Senior Regulatory Affairs Specialist
Cardinal Health
Mansfield, MA, USA
06.2021 - 06.2022
- Under direction, support new and modified product development projects to establish and integrate regulatory strategy into project activities
- Lead, under direction of manager, the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs
- Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
- Review design control documents including documents associated with design inputs and design outputs
- Review product labeling for compliance with global labeling regulations
- Review advertising and promotional literature for compliance with applicable regulations
- Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
- Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
- Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc
- Assists in the development, maintenance and implementation of regulatory procedures and SOPs
International Regulatory Affairs Specialist – RIMS
Cardinal Health
Mansfield, MA, USA
08.2019 - 06.2021
- Experience working with FDA and International Regulation
- Supporting Cardinal worldwide product registration
- Assisting country specific site registration requirements
- Keeping up to current regulatory databases to ensure accurate regulatory data
- Collaborating with cardinal regional regulatory terms in required registration documents upon fully understanding the local regulations
- Responsible for performing all duties in compliance with EU Medical Device regulation, FDA’s quality system regulation, GMP’s, ISO13485 and other international regulatory requirements
- Experience filing submissions for medical devices in the US and International Markets i.e., 510(k), technical files summary technical documents
- Under direction, preparing international submissions, rebranding submissions and maintaining existing regulatory approvals through letters to file, renewals etc
- Experience managing groups in the development of relevant data to complete a regulatory submission
- Procuring regulatory information from various sources to maintain product information databases
- Organizing regulatory information resources and tracks and controls submissions
- Acquires and maintains regulatory product files
- Attain, prepare and maintain Certificates of Foreign Government/ Certificate of Free Sale
- Assisting to give NCR updates for the International Regulatory Affairs Team
Regulatory Affairs – Publisher
Novo Nordisk
Bangalore, Karnataka, India
04.2017 - 05.2019
- Strong background and experience in the global regulatory industry
- Collaborated with scientific personnel for planning, preparation, publishing and quality control checks of submissions
- Played a pivotal role in managing and preparing regulatory documentation for submissions and also possess a good understanding of US FDA regulations, ICH, GCP, GMP, quality standards, quality management systems
- Submission experience in NDA, MAA for US, Canada, Australia and ROW submissions
- Highly adept in handling both paper and electronic submissions, with capabilities in managing life cycle of submission documents in eCTD submission format
- Performed document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
- Adhered to the required timelines for compiling and finalizing submissions with an ability to aid in document formatting
- Maintained the necessary consistency of submissions to match both company and health authority standards
- Enthusiastic and passionate to participate in company training and internal processes and exhibits 100% applicability, compliance and consistency
- Trained junior staff on processes and tools
Education
Masters In Industrial Pharmacy - Pharmaceutical Sciences
Manipal College of Pharmaceutical Sciences
Manipal, India06.2017
Bachelors In Pharmacy - Pharmaceutical Sciences
Nitte Gulabi Shetty Memorial Institute of Pharmacy
Nitte, India 06.2011
Skills
- Regulatory strategy
- Labeling compliance
- Pharmaceutical regulations
- Medical device regulations
- GxP knowledge
- Global regulatory affairs
- Regulatory submissions
- FDA submissions
- Global regulatory compliance
- Risk management
- Technical guidance
- ISO standards
- Technical documentation
Timeline
Senior Regulatory Affairs Specialist – Private brand products
Cardinal Health
06.2022 - Current
Senior Regulatory Affairs Specialist
Cardinal Health
06.2021 - 06.2022
International Regulatory Affairs Specialist – RIMS
Cardinal Health
08.2019 - 06.2021
Regulatory Affairs – Publisher
Novo Nordisk
04.2017 - 05.2019
Masters In Industrial Pharmacy - Pharmaceutical Sciences
Manipal College of Pharmaceutical Sciences
Bachelors In Pharmacy - Pharmaceutical Sciences
Nitte Gulabi Shetty Memorial Institute of Pharmacy