Documentation Officer

Senior Manager, Regulatory Affairs

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

Job Summary

To coordinate within team and third-party manufacturing/development sites to organize co-development projects which includes new submissions, deficiency responses and Product Life Cycle Management (PLCM) of approved products to various regions.

Job Responsibilities

• To lead the team for co-development and biosimilar projects including new submission, deficiency responses and PLCM activity for approved products in US and Canada market.
• To coordinate with third-party manufacturers /development sites for Co-development projects.
• Review of dossiers, deficiency responses and supplements/variations to various Regulatory Authorities, USFDA and Health Canada. 
• Responsible for coordinating internally and externally for New Product Launch of Co-development projects.
• Responsible for quality eCTD submissions to various Regulatory Authorities within the stipulated and agreed time frame.       
• To assess and provide regulatory strategy for the changes proposed by the different third-party manufacturers for co-development products.
• To track the regulatory approvals of submission and post approval variations US/Canada markets.
• Planning and allotment of workload to the team based on the priorities.
• Involved in various activities in facilitating the smooth functioning of the team and workload to meet targets.
• Ensures appropriate skilled resources are available and they have the appropriate training before execution of activities
• Ensures all team members comply with all applicable GMPs and follow Apotex’s Global Policies and SOPs
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures
• Guide the team on the relevant new submissions, compilation of deficiency responses and PLCM submissions.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate winning behaviours – Individual Accountability, Rigor & Discipline and Continuous improvement in day to day activities.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• 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.
• To adhere the EHS policy & procedure in routine activities.
• To involve in EHS related activities on need basis.
• All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  • M.Sc/M.Pharm/Ph.D
• Knowledge, Skills and Abilities
  • Sound understanding regulatory affairs submissions.
  • Expertise in product life cycle management.
  • People management skills.
  • Ability to learn and adapt quickly.
  • Ability to manage full workload across multiple projects.
  • Excellent verbal and written communication skills
• Experience
  • 15 to 20 years of experience in Regulatory Affairs activities which must include 3 to 4 years of experience in team/people management.

 

Exigences liées au poste

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

Experience Level

Senior Level