Regulatory Director – 11/21

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

This position’s responsibilities will include, but not be limited to the following:

  1. Responsible for regulatory submissions and maintaining submission information in a proper RA systems
  2. 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.
  3. Responsible for preparation of labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.
  4. Oversee the interviewing, hiring, training, and development of all department personnel, ensuring employees can function effectively in a team environment.

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:

10 years of experience in the pharmaceutical industry

Experience in statistical analysis

Excellent interpersonal, verbal and written communication skills

Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and eCTD publishing tools

Strong working experience in ANDA, NDA eCTD submissions.

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.