Job Summary
A global research consulting company has an open position for a Remote Regulatory Affairs Senior Associate.
Candidates will be responsible for the following:
- Reviewing investigator packages and authorize drug shipments to clinical sites
- Serving as Regulatory representative in department discussions and present issues accordingly
- Assisting in facilitating internal staff meetings and may assist in facilitating project team meetings
Skills and Requirements Include:
- Must be able to interface with international affiliates on regional regulatory strategy and implementation plans
- Must be able to conduct business development efforts, if assigned
- Must maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines
- Must be able to perform literature searches, prepare regulatory intelligence reports, and assemble documentation
