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Associate Director Of Regulatory Strategy

5+ years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: PhD/MD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, 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, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director of Regulatory Strategy

Location: Mountain View, CA (Remote)
Company: EPM Scientific
Employment Type: Full-time

Job Summary:
EPM Scientific is seeking an Associate Director of Regulatory Affairs - US Lead to develop and implement global regulatory strategies for securing and maintaining product approvals across US, EMA, Japan, Australia, and Canada. This role serves as the primary regulatory interface with product development teams, proactively mitigating regulatory risks and ensuring compliance with US regulations.

Key Responsibilities:

  • Act as the US Regulatory Leader, ensuring execution of regional regulatory strategies aligned with global registration plans.
  • Provide regulatory support across proof of concept (PoC), development, registration, and post-approval phases.
  • Lead and coordinate local project team members in developing regulatory strategies.
  • Ensure quality and content of submissions to Health Authorities.
  • May serve as a Global Regulatory Leader (GRL) for early-stage projects.
  • Lead regional Health Authority meetings and liaise with company governance boards.
  • Serve as the document owner for briefing books submitted to Health Authorities.
  • Research and interpret regulatory guidance to develop global regulatory functional plans.
  • Review and contribute to nonclinical, clinical, and CMC documentation (e.g., study reports, protocols, investigator brochures, CMC data).

Qualifications:

  • Advanced scientific degree (PhD, MD, PharmD) or a master’s degree with at least 5 years of drug development experience.
  • Experience in Oncology is a strong plus.
  • Global regulatory experience is preferred.
  • Ability to work in a fast-paced environment managing multiple demands.

Company Overview:
EPM Scientific partners with a top 10 pharmaceutical company that has rapidly expanded after launching at-home COVID diagnostic tests. The company is undergoing a major hiring campaign, adding over 200+ quality professionals to support post-market activities, complaint investigations, and regulatory compliance.