Specialist- Regulatory eCTD Submission

Parsippany, NJ

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.

RESPONSIBILITIES:

• 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

QUALIFICATIONS:

• Advance Degree in pharmaceutical/biological/computer/information system fields
• 2+ years of experience in related field.

BENEFITS:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Direct Hire
• 401K
• Company paid Holidays

Ask for: Harshita Berry

harshita@ajuliaexecutivesearch.com

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.

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