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. Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
2. Create documents in accordance with eCTD specifications.
3. Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
4. Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
5. Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
6. Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
7. Update and maintain the internal database as needed.
8. Comply with FDA guidelines/Company Policies of Data Integrity.
9. Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
10. Other duties as required or delegated
    
    
    

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.

.