- Consumer Data Scientist Puerto Diablo
- Jobleads-Us in Puerto Diablo, Vieques, Puerto Rico
- jobs
- 3 weeks ago
jobs description
Job Summary: Seeking an Associate Director, Global Regulatory Affairs with a Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field and 7 years of related experience.Key Responsibilities:• Global and US Regulatory Strategic Lead (GRL) for late-stage development in multiple indications, device platforms, and cell line changes.• Lead global regulatory oversight ...and execute regulatory activities for accountable individual projects.• Provide global experience of health authority interactions, including preparation meetings with FDA, EMA, BRDD, and PMDA.• Develop high-level global regulatory supplemental biologic application sBLA strategy and lead global submission strategy across multiple respiratory indications.Requirements:• Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field.• 7 years of related experience.• Up to 20% domestic and international travel required.Additional Information:• Full-time position with a salary range of $212,400.00 - $290,400.00 per year.• Apply online at https://jobs.takeda.com (search for Req # R0136180).
Puerto Diablo Vieques Puerto Rico