Sr. Regulatory Affairs, Study Start Up Specialist
JobgetherJob Description
📋 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.