Director of Regulatory Affairs

Job Summary

To support the IBD program, the full-time salaried Director of Regulatory Affairs will manage and oversee regulatory affairs activities, develop regulatory strategies for clinical trials, and lead global regulatory submissions while working remotely with occasional in-person meetings.

Key Responsibilities:

• Develop and implement regulatory strategies to facilitate clinical trials and marketing applications
• Prepare, review, and submit regulatory applications to health authorities, ensuring timely approvals
• Plan and lead health authority meetings, developing briefing materials and capturing action items

Required Qualifications:

• Bachelor's degree with 8-10 years of experience in pharmaceutical regulatory affairs or related fields
• Proven track record of managing complex regulatory submissions and clinical trial applications globally
• Strong knowledge of global pharmaceutical regulations, including FDA, EMA, and ICH requirements
• Proficiency in medical and technical writing for regulatory documents
• Experience with CMC regulatory, device, and/or diagnostic regulations