Sr. Regulatory Affairs, Study Start Up Specialist

📋 Description

• The Senior Regulatory Affairs, Study Start Up Specialist will manage regulatory submissions and

🎯 Requirements

• Bachelor’s degree or equivalent in Nursing, Pharmacy, Life Sciences, or related field.
• 3+ years of regulatory affairs experience in pharma/biotech/medical device/CRO.
• Experience managing clinical trial submissions across multiple Latin American countries.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Experience preparing, reviewing, submitting regulatory docs for clinical studies.
• Understanding of clinical trial processes, regulatory operations, and start-up activities.

🎁 Benefits

• Hybrid work model with flexibility to support work-life balance.
• Opportunity to contribute to global clinical research programs.
• Career development through mentoring, leadership training, and learning initiatives.
• Access to ongoing education and professional development resources.
• Opportunity to work with international teams across multiple countries/markets.
• Supportive environment focused on innovation and growth.