Role Description The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives. - Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. - Lead global/multinational submissions of complex large clinical trials. - Addresses Sponsor queries related to regulatory and submission requirements. - Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise. - Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance. - Peer review of documents and packages prepared by colleagues within regulatory team. - Develops/reviews Country ICFs. - Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites. - Develops/reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements. - Participates in Kick-off meetings, client audits, and other project related meetings according to the company/client needs. - Act as a mentor to new or junior colleagues within regulatory team. - Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics submissions. - Support Regulatory Country Intelligence activities. Qualifications - Bachelors' degree (or equivalent) in a scientific discipline. Regulatory Affairs is an asset. - 3-5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications. - Strong understanding of global regulatory requirements and guidelines in assigned countries/regions. - Experience in global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand). Experience of the regulatory process under EU-CTR. - Fluency in English with excellent oral and written skills, required. - Additional languages represent an asset. - Attention to detail and accuracy in work. - Ability to organize own work, prioritize different assignments, and work under pressure. - Versatile and comfortable in a multitasking environment. - Respect established timelines, expectations, priorities, and objectives. - Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014. Benefits - Flexible work schedule. - Permanent full-time position. - Company benefits package. - Ongoing learning and development. - Home-based position. Company Description At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. Indero is a Global Clinical Leader in Dermatology and Rheumatology. Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.

• Act as the Reg CMC lead for assigned programs, driving strategy, execution, and timelines. • Personally author sections of Module 2 and 3 (QOS, drug substance, drug product, comparability, stability, etc.). • Own CMC regulatory deliverables end-to-end with minimal oversight. • Lead and deliver global submissions (INDs, IMPDs, CTAs, amendments, annual reports) with a focus on timeliness, quality, and completeness. • Identify risks early and lead teams to resolution to keep programs on track. • Translate complex technical data into clear and concise narratives. • Lead preparation of CMC-related responses to HA questions. • Act as a connector and leader in discussions, not a passive participant. • Manage multiple programs, while prioritizing effectively. • Other duties as assigned.

• Provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the OSUCCC Clinical Trials Office. • Assists the Regulatory Manager with the oversight and monitoring of the regulatory research compliance function across all disease teams managed by the clinical trials office (CTO). • Serves as the subject matter expert for all regulatory compliance officers within the departments, reviews regulatory documents prior to submission to sponsors, IRB, FDA to ensure compliance. • Answers questions and provides technical support to junior members on the team. • Provides coverage/back up as needed for Regulatory manager and/or team members. • Manages complex submissions and assists junior team members with the process. • Participates in the development of SOPs and Processes for the regulatory team to stay current with the changing regulatory requirements and training. • Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CTO staff, and investigators. • Provides regulatory guidance, direction and support to all members of the research team. • Stays current on legislation, rules, regulations, procedures, and development; educates physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients. • Works with CTO Managers and coordinators as needed to ensure understanding of study protocols.

• Serve as the first human layer of review for expert call transcripts to detect and resolve any instances of material nonpublic and confidential information in accordance with internal protocols, applicable laws/regulations, and industry standards. • Complete due diligence review of each call, document any violations comprehensively, and escalate non-compliance with Tegus sourcing guidelines as necessary. • Conduct advanced research of financial reports and regulatory filings using internal databases and external resources to determine the extent to which information exists in the public domain. • Proactively manage internal and external communications while maintaining efficiency and adaptability in a fast-paced, time-sensitive environment. • Perform administrative tasks, including but not limited to, inputting, tracking, and maintaining accurate data on processes, transcripts, and workflows, while identifying opportunities to improve operational efficiency.