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Director, Regulatory Affairs, Ex-US

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

  • location_on
    Location New Philadelphia, Pennsylvania, United States of America
  • desktop_windows
    Job Type: Permanent
  • 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

Larimar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for patients with rare diseases. The Director of Regulatory Affairs, Ex-US will support the global regulatory strategy and lead regulatory activities for products in development, primarily in European and other global regions, while ensuring compliance with regulatory requirements.

Key responsibilities

  • Define, develop and lead regulatory strategies for complex development projects.
  • Provide tactical advice to project teams and stakeholders on program development and submissions.
  • Lead regulatory submissions to ex-US health authorities for timely approvals.
  • Collaborate on advertising and promotional materials and prepare OPDP submissions.
  • Prepare impact assessments of global regulatory intelligence.
  • Develop internal regulatory procedures and practices.
  • Serve as backup to other global regulatory activities.

Required skills

  • Bachelor's degree
  • 5 to 8 years of experience in Regulatory Affairs in the pharmaceutical industry
  • Experience with EMA, MHRA, and other European regulatory agencies
  • Understanding of GxP systems and Quality principles
  • Ability to research global regulatory guidance and precedents
  • Experience in authoring and reviewing documents for global Health Authority submissions
  • Excellent communication, time management, and project management skills
  • Continuous quality improvement mindset and attention to detail
  • Flexibility and mental agility

What the company offers

Not specified in the original listing.

Skills Required

Company Overview

Larimar Therapeutics
New Philadelphia, Pennsylvania, United States of America
14 Current Jobs Openings

Larimar Therapeutics Inc. is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. It utilizes a novel technology platform to deliver essential proteins to patients. The company's experienced management te... Read More

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