Regulatory Senior Manager
KVK Tech is looking for a Regulatory Senior Manager to join our team in Newtown PA.
This position’s 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 labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.
Benefits Include:
401(k) with matching
Health, Vision, Dental Insurance
Childcare Scholarship
Tuition Reimbursement
Bonus Pay + Merit Increases
Paid Time Off
Flexible Holidays
We are looking for applicants with:
- Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and eCTD publishing tools
- Strong working experience in ANDA, NDA eCTD submissions.
- Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance.
- Must demonstrate strong leadership skills
- Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines
- Good written and oral communication skills
- Experience in statistical analysis, process capability reviews with software
- Ability to act independently
- Excellent interpersonal, verbal and written communication skills
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you
