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 coordinate within team and third-party manufacturing/development sites for Co-development projects.


• Author/Review of dossiers, deficiency responses and supplements/variations to various Regulatory Authorities, like USFDA, Health Canada, TGA and Medsafe, etc.


• Responsible for coordinating internally and externally for New Product Launch of Co-development projects.


• Responsible for quality eCTD/CTD 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.


• 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.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  
  
  
  • M.Sc/B.Pharm/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
  
  
  
  • 8 to 10 years of experience in Regulatory Affairs activities which must include 3 to 4 years of experience in team/people management.
  
  
  
  

Exigences liées au poste