Director, Global Regulatory Affairs
New
P
Protara Therapeutics, Inc.Biotechnology
Work remotely or hybrid in the NYC officeFull-TimeDirector
Salary228,000 - 233,000 USD per year
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Job Details
- Experience
- Minimum of 10 years of pharmaceutical industry experience, at least 7 of which should include regulatory experience; 8–12+ years of regulatory affairs experience
- Required Skills
- Project Management
Requirements
- MD, Ph.D., or Pharm D. degree.
- Minimum 10 years of pharmaceutical industry experience.
- At least 7 years of specific regulatory affairs experience.
- Demonstrated success interacting with FDA, EMA, and global health authorities.
- Hands-on experience leading IND submissions and regulatory meetings.
- Strong understanding of CMC, nonclinical, and clinical requirements for biologics.
- Excellent written and verbal communication skills.
- Proficiency in MS Office Suite, specifically Excel.
- Experience in oncology, cell/gene therapy, or rare diseases.
Responsibilities
- Lead ex-US regulatory strategy and operational execution for clinical studies.
- Manage IND/CTA submissions for regions including South America, APAC, and EU.
- Interpret regulatory authorities’ feedback, policies, and guidelines.
- Develop study-level regulatory strategic plans.
- Prepare major clinical submissions for regulatory approval.
- Work with program teams to resolve complex project issues.
- Ensure quality and timeliness of IND/CTA submissions.
- Oversee CROs in the management of ex-US CTAs/INDs.
- Collaborate with internal functions to prepare and review submission documents.
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