Regulatory Director

KVK Tech is looking for a Regulatory Director to join our team in Newtown PA.

The Director of Regulatory Affairs is responsible for regulatory submissions and maintaining submission information in a proper RA system. 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.

In this position, your new career at KVK Tech will involve, but not be limited to the following:

1. Knowledge/Experience of Chemistry, Manufacturing and Control sections of original Abbreviated New Drug Applications (ANDA), amendments, supplements, and annual reports.
2. Knowledge/Experience of Chemistry, Manufacturing and Control sections of New Drug Applications (NDA), amendments, supplements, and annual reports.
3. Review of Drug Master Files (DMF), amendments, supplements and annual reports.
4. Strong knowledge of United States of Pharmacopoeia.
5. Comply to FDA guidelines/Company Policies of Data Integrity
6. Expert knowledge of Title 21 of Code of Federal Regulations, various US FDA guidance and ICH guidelines
   
   

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:

1. Minimum of 10 years of experience in the pharmaceutical industry
2. Good written and oral communication skills
3. Experience in statistical analysis, process capability reviews with software
4. Strong working experience in ANDA, NDA eCTD submissions.
5. Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance.
   
   

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.