Parsippany, New Jersey
15 days ago
Specialist- Regulatory eCTD Submission
Job Id: 9838
Are you looking to make a career change to a stable and growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including Medical, Dental and Vision. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Must study FDA and ICH guidance on Common Technical Document (CTD) / eCTD.
- Responsible for communicating with FDA eSub group.
- Must prepare and review documents for FDA submission.
- Must prepare Investigational New Drug Applications (INDs) / New Drug Applications (NDAs) /Amendments in eCTD and submit through FDA electronic submission gateway.
- Promotes department and company goodwill through pro-active employee communication and employee involvement.
- Perform other tasks as assigned
- Advance Degree in pharmaceutical/biological/computer/information system fields
- 2+ years of experience in related field.
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Direct Hire
- Company paid Holidays
Ask for: Harshita Berry
Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.