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CDO Health Regulatory Affairs Category Associate Manager

How can you help us create the Global Regulatory Team of the future?

We’re proud of our organisation and continually strive to be the best that we can be. The CDO Health Regulatory Affairs Category Associate Manager plays an essential role in shaping the future of Regulatory Affairs in Innovative products and ensuring we are an effective, well-connected organisation. 

 

Your assigned category will be complex and have diverse registration/regulatory requirements across multiple global markets.  They will interface with functional members of the assigned category project teams (e.g. R&D Category Manager, Commercial Category Manager, Clinical/Medical Affairs, PMO, Innovation) to ensure flawless design and execution of global strategies in compelling stakeholder friendly language to support the global business objectives. 

You will interact with R&D Globally as well as other key internal and external stakeholders to ensure that all Regulatory Dossier Creation activities are completed according to best practice, in a consistent approach across projects.

Working with the Category Manager, you will ensure the development of regulatory strategies to drive regulatory expertise and understanding at feasibility and throughout the project.  You will collaborate with Local Regulatory to define development plans and timings of projects and critical regulatory parameters in data and timings. 

 

Key responsibilities:

  • Manage a complex and diverse set of registration/regulatory requirements across multiple markets to enable the strategic delivery of a global pipeline.
  • Ensure execution of the global regulatory strategy into product development plans.
  • Develop and deliver innovative global regulatory strategies in their category.  
  • Work collaboratively with their team in order to define and implement the regulatory strategy.  
  • Work collaboratively within the R&D community to define global registration dossiers and technical documentation.  
  • Provide regulatory strategy assessments of internal and external commercial opportunities in concert with appropriate technical and regional/local regulatory input. 
  • Working with LRA, support and where necessary lead Health Authority meetings/negotiations in support of submission and approval of strategic new product registrations in critical markets. 
  • Work in partnership with the local regulatory teams to identify and be aware of key requirements and ensure that they are considered to deliver a ‘right first time’ approach to new product development.  
  • Influence externally where appropriate, industry led regulatory reviews and initiatives of direct relevance to RB, in-line with RB’s strategic vision.   
  • Take the regulatory lead in the preparation of responses to address significant safety, regulatory and PR issues in the assigned category.    
  • Support internal investigations into allegations of non-compliance.  
  • Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment.   
  • Ensure through dynamic resourcing that appropriate support is given to the innovation projects and team.  
  • Responsible for delivery of dossier/technical file to agreed time frames and collaborate across partner functions to ensure timely delivery of all information required, to enable robust and consistent project updates. 
  • Supports work required to refine regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market. 
  • Create strong and proactive relationships with all partner functions.

What experience are we looking for?

  1. Educated to honours degree level in a scientific field or equivalent experience.
  2. Relevant regulatory experience and knowledge in dossier / technical file creation and global registrations.
  3. Experience in different regulatory classifications  
  4. Knowledge of the regional and global regulatory environment and how it impacts regulatory dossiers and registration.
  5. Experience in preparing and submitting dossiers, variations and renewals. 
  6. Understanding of global product development practice, rules, regulations and guidelines.
  7. Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries. 
  8. Ability to consistently deliver to time, cost and quality standards in a high-pressure environment 


Job Segment: Medical, Healthcare

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