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Senior Director, Regulatory Affairs

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

  • location_on
    Location Jersey City, New Jersey, 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 Senior Director of Regulatory Affairs at Clinical Dynamix, Inc. is responsible for leading global regulatory activities related to medical product development and commercialization. This role requires expertise in regulatory strategy and compliance, ensuring that products are developed in alignment with applicable regulations while supporting the company's strategic goals.

Key responsibilities

  • Secure US and global regulatory marketing authorization for new products and updates
  • Develop and implement policies, processes, and SOPs for regulatory responsibilities
  • Formulate regulatory strategies for pipeline products
  • Anticipate regulatory obstacles and devise resolution strategies
  • Conduct global regulatory intelligence and monitor updates and discussions
  • Advance organizational awareness of regulations and identify training needs
  • Manage processes for maintaining annual licenses, registrations, and listings
  • Serve as the internal expert on regulatory and quality matters
  • Represent the company in external regulatory meetings

Required skills

  • Advanced degree in Life Sciences (PharmD, PhD, MD, MA)
  • 15+ years of experience in regulatory affairs with global responsibility
  • Knowledge of global regulatory agencies and processes
  • Record of successful medical product filings (INDs, NDAs, BLAs, MAAs)
  • Excellent writing and oral communication skills
  • Ability to build professional relationships with stakeholders
  • Experience in diverse therapeutic areas
  • Strong leadership skills and ability to mentor others
  • Experience in leading communications with regulatory authorities

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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