#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
...phone calls or facebook messages please. No Experience needed but is a major plus. On the job... ...detail upon the opportunity to interview. Assist in exam room obtaining demographics. Directly assisting Veterinary during exams, surgeries etc. Kennel cleaning...
We"re currently looking to recruit a 3rd Shift Quality Monitor to join our team. As a Quality Monitor you will be required to audit, inspect, and test in-process product in order ensure compliance to customer specifications. Primary focus of the Quality Monitor is to adhere...
...M.E. Wilson Summer Internship Program The M.E. Wilson Summer Internship is a paid 8-week program based in our Tampa office, designed... ...-on learning, professional training, and mentorship, allowing interns to gain real-world exposure to client services, sales, risk...
...isn't just a job, it's a seat at the table! We are hiring an Environmental Health & Safety (EHS) Compliance Specialist in our Fullerton CA location. In partnership with the EHS Manager onsite, you will be responsible for the development, implementation, evaluation, and...
...Summary: Creates and designs commercial HVAC products and parts by utilizing schematics, drawings and creative 3-D modeling to enhance or refine existing and future brand product line and manufacturing process. What Youll Do: Design and Documentation: Generate...