Senior Manager, Regulatory Affairs

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