Senior Regulatory Associate
Location Fully Remote
Global Regulatory Senior Associate
We are currently working with a multinational consumer goods company who are looking for a global regulatory senior associate, to work on their healthcare products.
The overall aim of the role is the development of regulatory strategies for the assigned projects with a commercial mind set, working with the Regulatory Senior Manager and Manager in driving regulatory expertise and understanding at feasibility and throughout the project. Collaborating with local regulatory teams to define development plans and timings of projects and critical regulatory parameters in data and timings.
The regulatory senior associate will be responsible for the creation and delivery of the product core dossier/technical file relating to a project. Working with the dossier/technical file authors to ensure consistency and ‘right first time’ approach, you will deliver dossiers/technical files or other product information on time and in line with the agreed regulatory strategy.
The position does have a strategic element, assisting the management team to identify regulatory possibilities to shape future policy, gather, disseminate & assess regulatory & regulatory competitive intelligence for assigned brands.
This position involves stakeholder management including Category R&D, Innovation, Local Reg, Supply and Marketing, and you will act as an interface between these teams.
Some main responsibilities of the role include:
- Work collaboratively with Snr Manager/Manager to define and implement the regulatory strategy.
- Support key innovation initiatives as required assigned by manager
- Work in partnership with the local regulatory teams to identify and be aware of key requirements and that they are considered to deliver a ‘right first time’ approach to new product development.
- Responsible for project management of Regulatory NPD requirements & dossier/technical file creation in line with the project strategy.
Ideally the successful candidate will be educated to honours degree level in a scientific field (or equivalent experience) and possess significant proven Regulatory Experience and knowledge in new product development strategy and dossier/technical file creation and global registrations.
This is a permanent position and comes with an attractive benefits package. If this sounds like the opportunity for you, apply now with your CV, and feel free contact Tom Kirkpatrick for more information.