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Senior Regulatory Affairs Associate

3 weeks ago

Manchester, United Kingdom Kenton Black Science & Engineering Full time

Senior Regulatory Affairs Associate
I am working in partnership with a leading healthcare manufacturer, who are a dynamic, and innovative company with a large portfolio of products. They specialise in the development of new products, using their unique technology platform. Due to growth in thebusiness, they are looking for a Senior Regulatory Affairs Associate to join the Regulatory Affairs Team.
The Role:

- Planning, preparing and filing of global regulatory submissions for marketing authorisations, variations, supplements, amendments, promotional materials, labelling and other regulatory submissions as required by the business.
- Act as internal regulatory consultant for labelling/packaging, artwork for commercial portfolio across the regions.
- Work with other Project Managers within the business to link regs requirements into other areas such as R&D, Quality and Marketing.
- Prioritise activities of each project individually, projects within the regs group and those across the wider business.
- Communicate project status within the Regs team and across the business.
- Coordination with external, regulatory stakeholders.
- Good background in Regulatory Affairs, ideally with experience within the Medical Devices, Pharmaceutical or Cosmetic industry.
- Self-motivated with the ability to deliver a high standard of work within agreed deadlines.
- Excellent interpersonal and organisational skills. Must be able to work well within a team and display strong problem-solving skills.
- Must work efficiently and be self-disciplined. Able to work well under pressure and to be able to identify the need to prioritise when required.