Shifa Javed

Skilled medical writer with a combined 6 years of experiences in the academic, biotech and medical device space across diverse therapeutic areas. Adept at collaborating with internal and external stakeholders to resolve regulatory enquiries, optimize operational processes, and contribute to the development of SOPs and reports. Proven expertise in evaluating medical device problems incident reporting, drafting regulatory documents, and ensuring compliance with ISO standards, Good Clinical Practices (GCP), and EU Medical Device Regulation (MDR)

During my study period, I gained comprehensive insights into Canadian and global drug and healthcare legislation, regulations, and guidelines, ensuring compliance and alignment with industry standards. I developed a strong understanding of how regulatory processes and manufacturing practices influence product quality and safety. My experience includes preparing thorough and accurate regulatory submissions, including supplemental documentation for the Therapeutic Product Program. I also applied principles of Good Manufacturing Practices (GMP) to maintain high-quality standards and regulatory compliance. Additionally, I honed my skills in negotiating and managing the regulatory review process, fostering effective communication with regulatory bodies to streamline approvals.