Policy, Planning and International Affairs Directorate

• Screen pharmaceuticals drug submissions such as NDSs, ANDSs, SNDSs, NCs , DINAs, and PDCs for compliance with set regulatory and scientific requirements• Support full life cycle management of drug submission and provide advice and guidelines to industry stakeholders and management • Participate in various Working Groups to streamline drug submission screening process, modify Standard Operating Procedures (SOPs), and guidance documents• Generate monthly Brand Safety Update Reports, and comparison drug submission filling reports between Australia’s Therapeutic Goods Administration (TGA) and Health Canada’s TPD• Provide orientation training for new employees and students

• Issued screening decisions for pharmaceuticals submissions such as NDSs, SNDSs, and NCs • Organized and participated in pre-submission meetings for NDS and SNDS with stakeholders• Corresponded with industry sponsors on a regular basis to clarify screening deficiencies • Actively participated in various Working Groups to develop Standard Operating Procedures (SOPs), guidance documents, policies, and training materials for internal use

• Prepared and submitted Natural Health Product (NHP) Licence Applications • Corresponded with Health Canada officials for deficiency clarifications and post-license amendments• Researched and written NHP labels, marketing materials and scientific articles • Prepared Batch File, Certificate of Analysis, and Specification of Finished Product documentations for NHPs• Assisted in compiling Product Master Files for foreign health product licensing and registration• Worked in conjunction with Quality Control team to conduct daily equipment inspection, monthly equipment calibration, and release of batch record

• Designed, promoted and supervised a summer camp program of 100 staff and children• Recruited and trained staff on camp curriculum and activities• Organized community outreach programs between the regional Member of Parliament and community members

• Instructed a diverse group of students ranging from 6-12 years old• Organized and assisted in all promotional activities for the summer camp