Regulatory Affairs Specialist

Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and/or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and contractual...

**Unit Management**: - Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites. - Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current...

**Responsibilities**:- Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure high quality standards- Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions. Includes oversight of EU (mainly), APAC, and North America submissions.- Review of regulatory documents...

Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. Prepare, distribute and follow-up on start-up documents with sites. Plan and track site start up activities and data using designated systems and...

The Training & Compliance Specialist (TCS) drives a culture of compliance within Clinical Research. This role evaluates the quality status of project deliverables by reviewing applicable project quality metrics and/documentation and identifies and evaluates potential risks and quality issues in collaboration with project team leadership and other relevant...

Acts as the primary regional representative for the execution and delivery of clinical project(s); cultivate excellent Sponsor relationships, provide project oversight, assisting with project delivery services as required, ensuring that projects are adequately and appropriately staffed, meet sponsors quality, schedule, and budgetary requirements, that...

Projects Managers with experience in Rheumatology are crucial to the success of Clinical Trials managed by Innovaderm. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.Great project managers go further than creating project plans and following up on...

Projects Managers are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected. Great project managers go further than creating project plans and following up on tasks. They show leadership to...

Projects Managers with experience in Rheumatology are crucial to the success of Clinical Trials managed by Innovaderm. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.Great project managers go further than creating project plans and following up on...

**Global SaaS | Subscription Continuity | Revenue Optimization | Stripe & PayPal**Our client is a digital product company that has been successfully operating since 2014. With a team of 100+ professionals, they develop and scale high-traffic SaaS products focused on the U.S. market. Their portfolio is built on **subscription-based models**, emphasizing...