• Reporting to the Registration Department Team Manager, you are responsible for all activities related to the obtention, follow-up and maintenance of Marketing Authorizations (MA) in France and Europe, including: • Submission and follow-up of Marketing Authorization applications at both national and European levels. • Preparation, submission and follow-up of regulatory evaluations with Competent Authorities for: pharmaceutical variations, MA renewals, Requests for Amendments to Product Information (DMI), regulatory variations, up to their practical implementation. • Monitoring product registration in the Generic Groups Directory. • Acting as an interface with internal departments, external experts, API manufacturers and contract manufacturing organizations (CMOs).

• Assist with tracking and organizing contract deliverables (CDRLs) • Support the scheduling and coordination of document submissions • Help prepare, review, and format reports and deliverables for submission • Participate in team meetings and assist with the documentation of action items • Coordinate with team members to ensure timelines and requirements are understood • Maintain organized records of all documentation and delivery statuses • Support process improvement efforts and documentation standardization

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. • Demonstrates diligence in protecting the confidentiality of each subject/patient. • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

Hey Future Daybreak Clinicians! At Daybreak Health, we’re building a world where every young person has access to the mental health support they need to thrive. As a clinician on our team, you’ll be part of a dedicated, compassionate community of therapists who are passionate about making a real impact. We value flexibility, efficiency, and collaboration, allowing you to focus on what matters most—helping students. If you’re looking for meaningful work, a supportive team, and the opportunity to grow, we’d love to have you join us! About the Role: Remote Mental Health Therapist (Georgia) We are looking for associate mental health clinicians to provide teletherapy services to students across Georgia. As a Remote Mental Health Therapist, you will play a key role in delivering high-quality care while collaborating with schools, caregivers, and community partners to ensure student success. We are currently working with the following license types: APC Supervision is FREE to all associates who meet our caseload requirements. What You’ll Do - Provide evidence-based teletherapy to students within our school district partnerships. - Build trusted relationships with students and their families. - Collaborate closely with school counselors and other providers to support student mental health. - Provide psychoeducation and guidance to parents/caregivers. - Participate in case consultations, team discussions, and ongoing training. - Contribute to the development and refinement of Daybreak Health’s clinical programs. Why Join Us? - Receive competitive pay ($35-45/hour) with guaranteed compensation for cancellations and no-shows. - Qualify for FREE Supervision with a Daybreak assigned supervisor under our specialized associate program. - Work remotely with flexible scheduling. - Join a supportive team with ongoing professional development opportunities. - Be part of a mission-driven organization making a difference in students’ lives. What Our Therapists Are Saying... "As we learn, we’re teaching each other. A lot of the interventions that I’ve used are things that I’ve learned from other clinicians. I really love the clinical collaboration which ensures that we provide the best supports for our young clients." "I feel so honored and privileged to work with this group of clinicians. You make me better everyday.” "I absolutely love working with my young clients. They are so real, honest, and....hilarious! They’re the ones inspiring me!” Equal Employment Opportunity At Daybreak Health, we embrace diversity and inclusion and are committed to equity and opportunity for all. We encourage individuals from all backgrounds to apply, including those from diverse communities such as race, ethnicity, gender identity, sexual orientation, ability, age, religion, and socioeconomic background. Pay Range $35—$45 USD