Regulatory Associate

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

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

  1. writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
  2. Review technical documents for accuracy and with supervision, determines acceptability for use in regulatory submissions (i.e. ANDA and NDA)
  3. Create documents in accordance with eCTD specifications.
  4. Update and maintain the internal database as needed
  5.  Comply with FDA guidelines/Company Policies of Data Integrity

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. At least 1 year experience with technical writing
  2. Minimum 3 years Pharma experience
  3. Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
  4. Continuous working knowledge of applicable FDA/ICH/DEA regulations
  5. Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred

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.