Senior Analyst, GBS GRA PLCM-GBS-PLCM G

Role Overview: ApoPharma, a member of the Apotex group of companies, focuses on discovering and developing new medicines to improve the quality of life for patients with debilitating and life-threatening diseases. The company's major research focus is on investigating the pathological role of iron in human disease and utilizing novel medicines to treat conditions affected by iron. Key Responsibilities: - Prepare quality post-launch Product Life-Cycle Management (PLCM) packages for different markets to ensure timely approval. - Maintain and complete regulatory documents promptly to ensure compliance in various markets. - Coordinate and compile deficiency responses in a timely manner, working with other functional areas to resolve issues related to regulatory submissions. - Evaluate and prepare post-approval supplements to manage the regulatory product life-cycle as required. - Review change control documents, provide accurate assessments for changes, and maintain regulatory databases with accurate information. - Coordinate with third-party manufacturers for document requirements for regulatory submissions. - Act as a backup for team members and provide support when necessary. - Communicate and follow up with departments for compilation and submission of PLCM submissions and query responses according to agreed timelines. - Ensure compliance with SOPs, RA policies & procedures, and regulatory guidelines, and interact with other departments to discuss and resolve regulatory issues. - Communicate with external sources such as agents and suppliers to request or provide relevant data for submissions. - Seek guidance from team members to enhance regulatory knowledge, work collaboratively towards achieving outcomes, and demonstrate organizational values. - Adhere to all compliance programs and policies, including Global Business Ethics, Quality, Safety, Environment, and HR policies. - Perform any other relevant duties as assigned. Qualifications Required: - Education: Post-graduate/graduate degree in Chemistry, Pharmacy, or Life Sciences. - Knowledge, Skills, and Abilities: Familiarity with post-approval change submission requirements and compilation of variation packages for US, Canada, EU, Australia/New Zealand, and other markets. - Experience: Minimum 1 year of experience in the US, Canada, EU, Australia/New Zealand, and other markets. (Note: The additional details of the company were not explicitly mentioned in the provided job description.),