Canada
Hi there! Thanks for stopping by! I am Greeva Bhatt, clinical Regulatory Affairs Specialist with a Master's Degree in Drug Regulatory Affairs from Northeastern University, currently a PEBC EE candidate (Ontario Pharmacist licensure). My experiences in the bio-pharmaceutical and MD field has helped me be well-versed in regulatory submissions, compliance, and regulatory change assessments. Proficient in Health Canada, FDA, EMA, and ICHQ7 regulations, as well as expertise in planning, drafting, and executing submissions across global regulatory frameworks. My current work experience includes PLM activities, change assessments, eQMS mastering (Veeva, Intelex, Power BI), clinical regulatory authoring (eCTDXpress), risk mitigation, CAPA initiations, CCPs, cross-functional teamwork, and Health Authority engagements while adhering to ICH-GCP, GVP, GMP, and ISO standards.
UHN company ⬧ Oversee the creation and upkeep of Class IIa medical device General Safety and Performance Requirements (GSPR) checklists and TDs in accordance with EU MDR 2017/745 Annex I and technical documentation for CE certification, making sure that all Class IIa devices fully comply with Annex II and III of the EU MDR. ⬧ Conduct thorough EU MDR, USFDA QMS gap evaluations, ensuring that the company's QMS complies with relevant regulatory requirements and MDCG guidelines. ⬧ Ensure regulatory clarity for non-clinical market entrance, develop and implement QA/RA strategic plans for Research Use Only (RUO) medical devices, such as organ perfusion systems. ⬧ Oversee complaints and complaint investigation records pertaining to research products, evaluate regulatory reportability, and assist in developing and revising internal clinical investigation and evaluation protocols.
Responsible for managing prescriptions for the psych ward medications for CAMH ACT teams, CASEY HOUSE (AIDS patient care home). Well-acquainted with using Mckesson Pacmed machine for packaging medicines and ParataMax for vial packaging. Assisting pharmacists by filling prescriptions for opioid treatment customers and responding to patients and nurses from various hospitals. Examine and comprehend regulatory requirements from organizations such as OCP and Health Canada. Create and put into effect rules that comply with drug safety laws and compounding in the pharmacy. Maintain narcotic records and medication documentation for quarterly audits. Keep an eye on compliance, communicate with Medisca, and guarantee that NAPRA guidelines are followed.
Lead and participated in the development, preparation and delivery of regulatory submissions for Health Canada Class II and Class III renewal filings, MDPR reports, and compliance documentation. Ensure compliance with ISO 13485, ISO 10993 and ICH Q7 for product lifecycle management and regulatory requirements. Conduct regulatory risk assessments and create mitigation strategies and Gantt charts to ensure compliance with global health authorities (EU MDR) in short timelines. Spearheaded voluntary recall actions and maintenance of global internal repositories with 100% compliance in previous recall initiatives. Provide regulatory expertise on procedural and documentation needs to ensure compliance with health authority standards, hospital special authorizations and internal audits.
Project completion of COA and specification alignment for vitamins and supplements. Assisting in preparation of final QA evaluation reports and submission to quality management team. Assisting with planning of quality assurance testing projects following functional specifications and comparing them with COAs. Collaborating with team members of SCI, Nestle warehouse and Nestle US team to retrieve current database related to vitamins and supplements regulatory specifications