- Associate Director, Global Regulatory Affairs 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