Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Director, Regulatory Sciences

Propharma
Propharma
7+ years
Not Disclosed
United States
1 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

Director, Regulatory Sciences – Senior Regulatory Affairs Leadership Job in the United States

Company: ProPharma
Job Title: Director, Regulatory Sciences
Location: United States
Job Type: Full-Time
Job ID: JR 9490


About ProPharma

ProPharma is a global life sciences consulting organization providing regulatory sciences, clinical research, pharmacovigilance, quality compliance, medical information, and R&D technology solutions to pharmaceutical, biotechnology, and medical device companies. With more than 20 years of industry expertise, ProPharma helps organizations accelerate product development, regulatory approvals, and commercialization activities while maintaining compliance and operational excellence.


Job Overview

ProPharma is seeking an experienced Director, Regulatory Sciences to lead strategic and operational regulatory affairs activities for pharmaceutical and biotechnology clients across the United States.

This senior leadership role is responsible for overseeing regulatory submission strategies, managing cross-functional regulatory projects, mentoring regulatory teams, and ensuring successful delivery of high-quality regulatory submissions and approvals.

The ideal candidate will possess deep expertise in FDA regulations, regulatory strategy, and pharmaceutical product development, along with proven leadership experience in regulatory affairs.


Experience Required

Experience Level

  • Senior-Level / Director-Level Position
  • Not suitable for freshers

Required Experience

  • Minimum 7+ years of experience in:
    • Regulatory Affairs
    • Pharmaceutical Industry
    • Regulatory Strategy
    • Regulatory Operations Leadership

Preferred Expertise

  • FDA Regulatory Submissions
  • Hatch-Waxman Act
  • Regulatory Approvals
  • Strategic Regulatory Consulting
  • Cross-Functional Regulatory Leadership

Educational Qualification

Required Qualification

  • Bachelor’s Degree in a relevant scientific discipline

Preferred Qualification

  • Advanced Degree preferred (MS, PhD, PharmD, or related)