Aakanksha Achanta

I’m a healthcare professional transitioning into the field of Regulatory Affairs, currently pursuing a Post-Graduation in Regulatory Affairs in Canada. With a background in dentistry and multiple certifications in healthcare quality, GMP, and compliance, I bring a strong foundation in health sciences, cross-functional collaboration, and documentation excellence. My regulatory interests span the entire product lifecycle — from development and clinical trials to post-market compliance. I have developed a deep understanding of key Regulatory Affairs departments and functions, including: Regulatory Strategy & Intelligence – Interpreting global regulations (Health Canada, FDA, EMA) and guiding development strategies. Regulatory Submissions – Preparing, compiling, and managing dossiers (e.g., NDS, CTA, ANDS, eCTD, ePLA). CMC Regulatory Affairs – Supporting Chemistry, Manufacturing, and Controls sections, ensuring GMP-aligned product quality. Clinical Regulatory Affairs – Assisting with Clinical Trial Applications, ethics board approvals, and regulatory compliance. Labeling & Product Information – Drafting and maintaining Product Monographs, SPCs, and promotional labeling. Advertising & Promotion Compliance – Reviewing promotional materials for alignment with regulatory-approved claims. Post-Approval Regulatory Affairs – Managing lifecycle activities like changes to approved products and renewals. Pharmacovigilance Interface – Supporting safety reporting (e.g., CIOMS, SUSARs, PSURs) in alignment with regulatory timelines. Regulatory Compliance – Ensuring readiness for inspections, audits, and adherence to GMP, GCP, and GLP standards. Special Product Categories – Knowledge of Biologics, Biosimilars, Generics, Natural Health Products (NHPs), and Medical Devices. Regulatory Operations – Experience with electronic submissions (eCTD), document management systems, and publishing standards. Regulatory Project Management – Coordinating submissions, stakeholder communications, and Health Authority meetings. Global Regulatory Affairs – Understanding of region-specific requirements (Canada, US, EU) and international submissions. Cosmetic Regulatory Affairs – Understanding ingredient safety, INCI compliance, claims substantiation, and cosmetic notification systems (e.g., Canada’s CNF, EU CPNP).

Developed key skills in fast-paced, detail-oriented environment, seeking to transition into new field. Demonstrates expertise in identifying inconsistencies and ensuring document accuracy. Ready to leverage analytical and organizational abilities to contribute to new professional challenge.

Offering meticulous and organized approach, ready to learn and thrive in document review environment. Brings understanding of document management principles and ability to quickly adapt to new systems. Ready to use and develop critical thinking and analytical skills in [Desired Position] role.