Location: Remote (Supporting EU based team)
Duration: 12 Months
Hours per week: Ad-Hoc
Start Date: ASAP
Job Description: Our client is looking for a Global Regulatory Consultant who specializes in European strategy development. This will be an Ad – Hoc ongoing assignment for someone who can act as a sounding board, supporting the team as they take on European development. Looking for strong experience with EMA, CHMP procedures, and someone able to author early drafts of responses to Health authority questions, working with cross functional teams to get input and refine documents; briefing documents, scientific advice questions and answer and response to list of questions during MAA review. This expansion is part of a broader global expansion as the client moves into additional markets including China, Canada, LATAM, etc. Experience with oral inhaled product (OIP) guidelines is a huge plus.
Skills: Regulatory Affairs, Regulatory Strategy, EMA, MAA, Oral Inhaled Product
Education: Experience outweighs degree