Manager, Regulatory Affairs

Job Summary

This role encompasses managing  of regulatory submissions for products in Apotex’s Branded Portfolio as well as leading regulatory strategy development and execution for those products.    The role involves liaising with internal and external team members to drive/deliver a successful regulatory filing, approval and launch.  It also involves identification of, and participation in resolution of complex issues.

Job Responsibilities

• Responsible for managing the preparation and review of quality regulatory submissions to ensure timely approval
• Responsible for managing the preparation for and leading pre-submission meetings with the regulator
• Responsible for managing the maintenance and timely completion of regulatory documents to support regulatory compliance
• Accountable for assessing, coordinating and managing compilation of deficiency responses in a timely manner and in collaboration with internal and external stakeholders.
• Works with other functional areas/external partners to resolve issues related to information for regulatory submissions.
• Evaluates strategy, manages and reviews post approval changes to support the regulatory product life cycle, as applicable.
• Reviews change control documents, as required.
• Assists in product launch activities, as required.
• Maintains regulatory databases to ensure accuracy of information.
• Works as a member of a team to achieve all outcomes
• Interacts with other applicable departments within Apotex and with external partners to discuss and provide solutions to regulatory issues and/or problems.
• Communicates with external partners to request and/or provide data relevant to submissions.
• Contributes to resolution of complex issues relating to submissions.
• Interprets and applies regulatory guidelines and policies.
• Seeks guidance from other team members to enhance regulatory knowledge.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • BSc degree or equivalent in Chemistry, Pharmacy or Life Sciences. Diploma from an RA program would be an asset. M.Sc. preferred.
    
    
• Knowledge, Skills and Abilities
  • Strong oral / written communication, organizational and interpersonal skills.
  • Attention to detail.
  • Computer literacy in Microsoft Office and Adobe Acrobat. Experience with software for publishing electronic submissions in eCTD format would be an asset
    
    
• Experience
  • Minimum 5-10 years pharmaceutical experience, in an RA role
  • Experience with branded products is preferred
  • Experience with North American markets; experience with other major regulated markets (ex/ EU, AUS) is an asset