Regulatory Affairs Specialist / Manager

26 Sep 2019
24 Oct 2019
Job Type
Contract Type
Evolve is recruiting for an international, family-owned Healthcare company with market-leading products in the Woundcare market. Our client is seeking an enthusiastic and committed Regulatory Affairs professional to work at Specialist or Managerial level, depending on experience. Based from home in the UK, the successful candidate will be responsible for the creation, assembly, and publication of U.S. FDA submissions related to topical/ Woundcare drugs and maintenance of these approvals.
Key roles and responsibilities for the Regulatory Affairs Specialist / Manager
* You will be responsible for managing the compilation of drug submissions to the U.S. FDA and other competent authorities in support of new development activities as well as marketed product maintenance activities.
* Regulatory project work and timeline planning.
* You will own the CTD submission and will be responsible for writing Module 4 and/or Module 5 and other Modules with the help of colleagues.
* 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.
Minimum requirements for the Regulatory Affairs Specialist / Manager
* You will have demonstrable experience in eCTD compilation for topical/ Woundcare drugs for U.S. and/or EU submissions.
* Chemical background is required.
* PhD/Master's degree in Industrial Pharmacy/Pharmaceutical Sciences.
* Fluency in English, both written and spoken.
Recruitment Process:
2 stage process.
Flexible salary and benefits DOE.
If you want to hear more about this role please send us your CV by clicking 'apply now