A global medical device company is looking to bring on a Senior Regulatory Affairs Specialist to their rapidly growing pharmaceutical/combination products team. They are looking for a motivated professional to operate with little to no supervision and be a go to team member.
The Senior Regulatory Specialist will be responsible for:
- Responding to queries from Health Authorities, primarily FDA
- Driving Regulatory Strategy for US based submissions
- Leading full life-cycle Regulatory submissions for pharmaceutical and combination products
- Supporting other product teams on global submissions and maintenance (EU, Health Canada, etc.)
The Senior Regulatory Specialist should have the following qualifications:
- 7-10 years within Regulatory Affairs
- Background working hands on with 510(k) submissions
- Experience with pharmaceutical submissions from a Regulatory CMC perspective
- Knowledge of both FDA and EMA regulations
- Strong technical writing skills
If you are interested in this position, please apply here.