Global Regulatory Consultant (OIP Products) (233240) Remote (Supporting EU based team)

Engineering Services | Healthcare IT | Life Sciences & Technology

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


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
Remote, United States

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