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Director Regulatory Affairs - CMC

Date Posted: Jun 23, 2026
Yearly: USD - USD
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Job Detail

  • location_on
    Location San Diego, Baja California, United States of America
  • desktop_windows
    Job Type: Any
  • schedule
    Shift:
  • analytics
    Career Level:
  • group
    Positions:
  • calendar_view_day
    Experience:
  • male
    Gender: No Preference
  • school
    Degree:
  • calendar_month
    Apply Before: Sep 21, 2026
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Job Description

Overview

The Director of Regulatory Affairs - CMC at Clinical Dynamix, Inc. is responsible for the strategic leadership in regulatory CMC for assigned commercial and development projects. This role ensures compliance with regulatory standards and facilitates the successful preparation and submission of various regulatory documents to achieve timely approvals.

Key responsibilities

  • Lead regulatory CMC strategy for commercial and development projects
  • Prepare and maintain IND/CTA submissions and update activities
  • Interact with regulatory agencies and prepare for milestone meetings
  • Develop CMC regulatory strategies for optimal product development
  • Provide guidance on global regulatory CMC requirements
  • Manage preparation of regulatory submissions (IND/CTA/MAA/NDA/BLA)
  • Engage with stakeholders to influence regulatory decision making
  • Act as regulatory CMC liaison with partners and manufacturers
  • Select, develop, and evaluate personnel for efficient operation

Required skills

  • BS/BA degree and 12+ years of Regulatory Affairs experience in Pharmaceuticals/Biotech
  • Project regulatory leadership in CMC aspects for small molecules, biologics, or gene therapies
  • Leadership experience in marketing approval negotiation
  • Master's degree preferred with 10+ years of experience, or PhD with 7+ years
  • Industry-leading knowledge and deep understanding of FDA and EMA regulations
  • Strong leadership, coaching, and employee development skills
  • Excellent written, presentation, and verbal communication skills
  • Ability to influence others at all organizational levels
  • Proactive and innovative problem-solving skills

What the company offers

Not specified in the original listing.

Skills Required

Company Overview

Clinical Dynamix, Inc.
San Diego, Baja California, United States of America
4 Current Jobs Openings

Clinical Dynamix, Inc. focuses on providing expertise in regulatory affairs for the medical product industry. The company aims to ensure compliance with all applicable regulations to facilitate the successful development and commercialization of medi... Read More

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