Regulatory Affair Specialist (5 days Office Hours, Pharmaceutical, Healthcare) #HDC

Regulatory Affair Specialist (5 days Office Hours, Pharmaceutical, Healthcare) #HDC

Summary:

The Regulatory Affairs Specialist is responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position, you will also review and evaluate technical and scientific data and reports required for submission in support of global products.

What you'll be doing:

1. Supports regulatory project plan execution
2. Maintain awareness of regulatory requirements and ensure continued learning
3. Maintain regulatory files in a format consistent with requirements
4. Participate as an active team member of project teams as required
5. Compile and prepare responses to questions from regulatory authorities according to plan
6. Edit and proofread regulatory documentation
7. Assist in preparation and review of labeling, SOPs, and other departmental documents
8. Compile under supervision regulatory documents for submission
9. Track status and progress of regulatory documentation
10. Understand Regulatory Affairs' position in small project teams

What you'll bring:

1. Bachelor’s degree or equivalent in a relevant scientific discipline
2. Regulatory experience (not mandatory) preferably within a healthcare environment
3. Administrative and project management skills
4. Ability to contribute to multiple projects from a regulatory affairs perspective
5. Ability to multitask and prioritize
6. Interpersonal and communication skills