• Perform tasks at a country level associated with Site Activation (SA) activities • Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions • Distribute completed documents to sites and internal project team members • Prepare site regulatory documents, reviewing for completeness and accuracy • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information • Review and provide feedback to management on site performance metrics • Review, establish and agree on project planning and project timelines • Ensure monitoring measures are in place and implement contingency plan as needed • Inform team members of completion of regulatory and contractual documents for individual sites • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines • Provide local expertise to SAMs and project team during initial and on-going project timeline planning • Perform quality control of documents provided by sites.

Role Description We are currently seeking a Senior Associate Regulatory Submissions in Türkiye. In this role, you will be embedded within our Functional Service Provider (FSP) department, working closely with an international client in a global, matrix environment. You will be responsible for the preparation, submission, and maintenance of clinical trial authorizations, ensuring compliance with local and international regulatory requirements. - Prepare, submit, and maintain clinical trial applications (CTAs) - Ensure compliance with local and global regulatory requirements - Manage multiple regulatory submissions and projects within tight timelines - Collaborate with cross-functional and international stakeholders - Interpret regulatory guidelines and ensure accurate implementation - Support regulatory activities across the clinical development lifecycle Qualifications - Bachelor’s or advanced degree in Life Sciences, Pharmacy, Medicine, or related field - Minimum 4 years of experience in Regulatory Affairs within pharma or biotech - Proven experience in clinical trial submissions and authorizations - Strong understanding of ICH-GCP, GMP, and CTA/IND processes - Experience working in global, matrix organizations - Ability to manage multiple projects and deadlines Requirements - Strong knowledge of local clinical trial regulations and submission procedures in Türkiye - Understanding of the drug development process and regulatory lifecycle - Excellent document preparation and review skills - High attention to detail and regulatory accuracy Company Description

Role Description Senior Regulatory Affairs Associate will be responsible for managing and maintaining regulatory data, supporting EMA submissions, and ensuring compliance with European regulatory requirements. The role involves hands-on experience with xEVMPD, Veeva Vault RIM, and lifecycle management activities across authorized and investigational medicinal products. - Validate, maintain, and manage regulatory data for medicinal products in compliance with EMA guidelines. - Perform xEVMPD submissions via EMA Gateway and monitor acknowledgements using Register/AgXchange, EV Web, and Veeva Vault. - Support Product Lifecycle Management (PLM) activities, including variations, renewals, and regulatory updates for CAPs and non-CAPs. - Execute Post-Marketing Surveillance (PMS) and Product Update Information (PUI) activities, ensuring timely and accurate submissions. - Prepare and manage EMA deliverables such as eAF (electronic Application Forms) and eSMP (electronic Summary of Product Characteristics). - Handle submission and maintenance of regulatory documents including SmPC, PIL, and Health Authority communications. - Work on regulatory procedures such as xEVMPD, IDMP, CTA, MAA, and lifecycle management activities. - Utilize Veeva Vault RIM for submissions, tracking, and regulatory data management. - Ensure accurate data aggregation, mapping, and consistency across multiple regulatory systems and documents (RIMS, DMS). - Collaborate with cross-functional teams to ensure compliance and timely regulatory submissions. Qualifications - Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field. - Proven experience in Regulatory Affairs with focus on EMA submissions and xEVMPD. - Hands-on experience with Veeva Vault RIM and regulatory submission tools. - Strong knowledge of EU regulatory processes (CTA, MAA, IDMP, lifecycle management). - Familiarity with regulatory systems such as RIMS and DMS. - Proficiency in Microsoft 365 tools (Excel, Teams, SharePoint). - Strong analytical skills with ability to collect, interpret, and map complex data. - High attention to detail and strong organizational skills. - Effective communication and teamwork abilities.

• Support Compliance Management Division for legal compliance • Ensure good standing with governmental agencies • Review and renew licenses through NMLS • Prepare and submit license applications • Monitor continuing education requirements for MLOs • Perform compliance checks periodically • Prepare various reports and renewals • Maintain tracking system for deadlines • Provide guidance regarding licensing matters