Operations Specialist 2, Regulatory Reporting

**Job Overview** We are seeking a dedicated and detail-oriented professional to join our team as a Operations Specialist 1. In this role, you will provide critical phone support to healthcare professionals and patients, handling medical inquiries, adverse events, product quality complaints, and other relevant calls. This position does not involve commercial...

**Regulatory Publishing Specialist** The Regulatory Publishing Specialist provides experienced moderate, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for product milestones. Serves in...

As a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Regulatory advice to drug development is key to ensuring our clients pursue first time right strategies to overall product development and to clinical programme...

Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts the manager to quality or timeline issues. Participates in project teams and may lead...

**Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under general supervision,...

**Regulatory & Start Up Specialist, c**FSP - US/CAN Support** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site...

**Regulatory & Start Up Specialist, c**FSP.** Location: Mexico - Full home based **Job Overview** This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a **point of contact for investigative sites and the study team members.** This includes supporting **site qualification**, site...

Essential Functions Receives, prepares and submits safety reports to applicable parties. Ensures that all reports are compliant with regulatory timelines and country legislation and monitors this on a regular basis. Leads large scale projects effectively, ensuring safety reports are submitted in accordance with the agreed processes and regulatory...

Essential Functions Receives, prepares and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation. Assists in producing metrics and alerts manager to any quality or timeline issues. Participates on...

**POSITION TITLE**: Regulatory Affairs Specialist **REPORTS TO**: Manager, Regulatory Affairs or Designee **BASIC FUNCTIONS**: **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory...

We are looking for a **Regulatory & Start Up Specialist** to join our cFSP team in a Home Based role! **Location**: Argentina & México **What You´ll Do** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...

We're on the lookout for an experienced coordinator with experience in eCommerce Operations to join our team and help keep things running smoothly for our jewelry brand. As the Operations Specialist, he/she will handle tasks like managing suppliers, inventory, and purchases, optimizing our processes, and managing OPS-related projects/initiatives. It's all...

**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...

**Elevate Your Career as an Operations Specialist at Icalia Labs** Are you ready to drive operational excellence and client success in a cutting-edge environment? Icalia Labs is on the lookout for a dynamic Operations Specialist who excels in project management and client engagement. This role is your opportunity to become a cornerstone of our innovative...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office - Acts as liaison with internal stakeholders in the provision of these services. - Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory...

Summarized Purpose: Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists with allocation of work tasks to safety reporting team...

We are looking for a **Regulatory & Start Up Specialist** to join our FSP team in a Home Based role! **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...

The **Payroll Specialist I, Language Services**, will work with the Language Operations Managers on correcting and approving time cards for all interpreters before each payroll cycle. This included punch corrections, entering missed PTO, bereavement hours, etc. **Responsibilities**: - Accurately process time cards for several language teams weekly. -...

**Based in Mexico (remote)**: **Salary: Competitive + Bonus + Benefits**: If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere, then we want to hear from you! Join us to help improve peoples’ lives and make healthcare better for everyone! **Why Pharmanovia?**: Pharmanovia is a dynamic, fast-growing...

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: Provides experienced strategic, expedient and efficient preparation of client electronic submission deliverables and dossier that meet current local, regional and ICH regulatory and technical requirements. Ensures successful regulatory review outcomes for...