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This positions responsibilities will include, but not be limited to the following:

Responsible for regulatory submissions and maintaining submission information in a proper RA systems. The incumbent works cross-functionally with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labelling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.

Requirements

1. Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and eCTD publishing tools
2. Knowledge/Experience of Chemistry, Manufacturing and Control sections of original Abbreviated New Drug Applications (ANDA), amendments, supplements, and annual reports.
3. Strong working experience in ANDA, NDA eCTD submissions.
4. Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance.
5. Must demonstrate strong leadership skills
6. Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines
7. Good written and oral communication skills
8. Experience in statistical analysis, process capability reviews with software
9. Ability to act independently
10. Excellent interpersonal, verbal and written communications skills

Benefits

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays