#Exciting opportunity to join in global innovative drug development team, work with seasoned RA leader for US/EU/Japan registration for Phase II/III IND/NDA approvals! #
Responsibilities:
· This role supports multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines
· Assist and help prepare and submit regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
· Follow up on global regulatory initiatives in preparation and submission of global marketing authorization applications
· Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices and timelines to ensure consistency and completeness to standards for all regulatory submission
· Manage regulatory infrastructure (document management system)
Required Education/Qualifications/Skills:
· Bachelor's degree (scientific or clinical background desirable) required; advanced degree preferred
· Minimum 5 years of the pharmaceutical or biotechnology industry required at least 3 years’ experience in Innovative drug global registration
· Experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions
· Experience with preparation and review of electronic format (eCTD) submissions
· Direct interaction with FDA is preferred Experience in submission writing and review experience are essential
· Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter
· Strong interpersonal skills to collaborate effectively across multiple functional areas
...through the Job description and do let me know if you are interested. Please attach your Updated Resume. Job Title: Embedded Tester (DVT Role) Job Location: Alameda CA Job Type- Contract position Note-White Box /Black Box Testing exp. is mandatory...
...JUNIOR DESIGN MANAGER At Americaribe, we are more than builderswe are innovators, problem-solvers, and teammates. Building for Life means creating structures that stand the test of time while fostering a workplace where talent thrives. We take pride in our culture...
...Wisconsin Education Association Council Organizer Based in North / Northcentral Wisconsin JOB TITLE: Organizer ~ North... ...units within Wisconsin both teacher and education support professionals. This position works northwest and northcentral Wisconsin, specifically...
...enjoy providing exceptional guest service then this is the job for you. No previous commercial driving experience is required, and paid CDL training and testing are provided. Job Specifications: Housing: May Be Available Expected Pay Range: $25.00 - $27.53 /...
...Assistant General Manager (AGM) position is to assist Branch management in tactically executing complex QSR or Casual Dine or similar restaurant management operations. The AGM ensures the restaurant is clean, ready for business, staffed, and operates to high operational...