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Regulatory Affairs Manager, USA

USA, Ohio, Delaware /
Permanent/Long Term /
US$120000 - US$140000 per annum
J131046

Incredible opportunity to join a growing International wound care organisation in their new office in Delaware as a Regulatory Affairs Manager.

We are excited to be working on a Regulatory Affairs Manager role with one of our leading clients - They are an international, entrepreneurial, family owned wound and skin care group headquartered in Luxembourg with local subsidiaries in Belgium, the Netherlands, Germany and the UK and a network of distributors in other countries.

The employer is looking for a driven individual who has at least 5 years' experience in Regulatory Affairs, specifically in Drugs. The successful candidate would also need to have demonstrated experience in eCTD compilation for topical/dermatological drugs for U.S. and/or EU submissions.

You would be joining a new team that is targeting the implementation of the organisation's products into the USA. This exciting role will allow you to join this incredible organisation at a very exciting time.

Location

USA - Delaware

Key Responsibilities

  • Responsible for the creation, assembly, and publication of U.S. FDA submissions related to drugs and maintenance of these approvals
  • Regulatory project work and timeline planning
  • Adherence to required submission timelines, health authority publishing specifications, relevant legislation and internal working practices
  • Liaison with several departments in order to ensure that documents are compliant and submission ready
  • Work with document authors to ensure that documents comply with current U.S. FDA regulatory guidance/template specifications
  • Provision of feedback to your line manager regarding submission progress
  • Ownership of the CTD's submission
  • Ownership of the first eCTD within the CDER division of the FDA

Package

  • $120k - $140k Basic + Bonus
  • Company Car + Package
  • Joining a very well established organisation at an exciting time

Key Requirements

  • 5+ years of experience of Regulatory Affairs in drugs
  • Demonstrated experience in eCTD compilation for topical/dermatological drugs for U.S. and/or EU submissions
  • FDA experience is required
  • Chemical background is required
  • PhD/Master's degree in Industrial Pharmacy/Pharmaceutical Sciences or equivalent based on relevant experience
  • Knowledge in U.S. FDA drug regulatory requirements
  • (Pre)-clinical background
  • Ability to read and understand FDA regulations, guidance documents, test reports and technical/chemical product information
  • Submission authoring experience

What Happens Next?

If you wish to find out more, please click the 'Apply' button. This will send a notification to the consultant looking after this vacancy who will get in touch at a suitable time to share further details on this opportunity. Any communication will be in complete confidence, without obligation and we will NOT send your details to any practice unless you give us your permission, so there is nothing to lose in finding out more!

If you wish to contact us about this opportunity and other suitable positions, please email us on medicalsales@prospect-health.com or call our Medical Devices team on 01423 813456.

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