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AD​/Director, Regulatory Affairs CMC

Job in Columbus, Franklin County, Ohio, 43224, USA
Listing for: Scorpion Therapeutics
Full Time position
Listed on 2026-10-09
Job specializations:
  • Healthcare
    Healthcare Compliance
  • Pharmaceutical
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 190000 - 285000 USD Yearly USD 190000.00 285000.00 YEAR
Job Description & How to Apply Below
Role

Regulatory Affairs CMC professional focused on global regulatory strategy and dossier preparation for drug development in biopharma, reporting to the Executive Director.

Responsibilities
  • develop CMC strategies
  • manage the creation and submission of regulatory documentation (including ROW marketing applications)
  • coordinate responses to health authority questions
  • support interactions with regulators
  • ensure compliance with global regulations
Qualifications
  • minimum 7 years in pharmaceutical/regulatory CMC functions
  • bachelor's degree in life sciences or related field
  • excellent communication and project management skills
  • proficiency with document management systems like Veeva
  • demonstrated ability to leverage AI tools for efficiency

High Value: involvement in biopharma drug development, with emphasis on CMC regulatory processes, global compliance, and cross-functional collaboration.

Location

remote U.S. role requiring quarterly visits to San Francisco; salary range $190,000-$285,000 USD.

This Full Time opening is for the AD/Director, Regulatory Affairs CMC role at Scorpion Therapeutics.

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