Regulatory Start Up Manager/senior Regulatory Start

At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....

We are looking for an experienced regulatory ecotoxicologist to work as a technical specialist in a multi-disciplinary registrations team. The role will involve acting as the department ecotox expert, you will mentor more junior ecotoxicologists and provide expert advice and guidance to external stakeholders. The role will involve supporting large...

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

**Job Overview** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Essential Functions** - Oversee the execution of Site Activation (including pre-award/bid defense...

**Associate Study Start-Up Manager** **IQVIA Biotech** Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. **Essential Functions**: - Oversee the execution of Site...

The Director, Start-Up is responsible for providing leadership and oversight to site contracting, and site activation teams, ensuring alignment with study and site activation timelines. The Director, Start-Up will provide leadership to functional leads of Site Selection and Site Contracting. The Director, Start Up has line management responsibility for...

You will 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. The role may also include maintenance activities. This is not a line management position but requires...

The Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...

Principal Accountabilities - Real time monitoring and analysis of changes in the regulatory landscape for an assigned set of countries - Prepares and/or reviews regulatory documentation in area of expertise, as appropriate - Management of the content provided by our network of consultants and participate in the identification and evaluation of new Local...