Executive, GRA PLCM

As a Regulatory Affairs Specialist at Apotex Inc., you will be responsible for managing the product life-cycle of Apotex products in identified markets. Your duties will include maintaining documentation/database records, leading regulatory affairs projects, and preparing submission and approval notifications for applications submitted to Regulatory agencies. Key Responsibilities: - Provide support and regulatory guidance to a team in completing projects supporting regulatory submissions. - Prepare and review quality regulatory PLCM submissions for various markets to ensure timely approval. - Maintain and complete regulatory documents to support regulatory compliance in various markets. - Assess, coordinate, and compile deficiency responses in a timely manner. - Collaborate with other functional areas to resolve issues related to information for regulatory submissions. - Evaluate, prepare, and review post-approval supplements to manage the regulatory product life-cycle. - Review change control forms and provide accurate assessments for changes being assessed. - Maintain regulatory databases and established trackers to ensure accuracy of information. - Coordinate with third-party manufacturers for document requirements for regulatory submissions. - Act as a backup for team members and provide support as needed. - Communicate and follow-up with respective departments for compilation and submission of PLCM submissions and query responses. - Interpret and ensure compliance with SOPs, RA policies & procedures, and regulatory guidelines. - Interact with other departments within Apotex to discuss and provide solutions to regulatory issues. - Communicate with external sources such as agents and suppliers to request and provide relevant data for submissions. - Demonstrate organizational values of Collaboration, Courage, Perseverance, and Passion. - Adhere to all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. Qualifications Required: - Education: Post-graduate/Graduate degree in Chemistry/Pharmacy/Life Sciences. - Knowledge, Skills, and Abilities: Understanding of post-approval change submission requirements and compilation of variation packages for US/CAN/EU/AUS-NZ/ROW markets. - Experience: Minimum 3 years of experience in US/CAN/EU/AUS-NZ/ROW markets.,