Regulatory Lead, SSU (United Kingdom) - (15610)

Description

Do you want to be part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.

At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

We are currently are looking to strengthen our Ethics and Regulatory department within Europe and are seeking an experienced Regulatory Lead to be based in Europe.

A brief summary of duties you will be involved in as a Regulatory Lead, Site Start Up:
• Acting as a key point of contact with the sponsor and INC team regarding all Regulatory activities for the assigned study
• Overseeing all associates assigned to work on the regulatory, ethics and essential document portion of the study.
• Assuming responsibility on deliverables at the project level
• The planning, coordination and oversight of all processes involved in gaining approvals required in each country for a clinical trial to commence. This will include competent authority approvals, ethics committee approvals, import license approvals, radiation approval, tissue/biological sample export and any other local approvals required in a given country.
• Dealing with multiple countries and studies at any given time.

Qualifications

To succeed in this role you will need the following skills/experience:

• Degree educated or equivalent in a science or healthcare field
• Direct experience making CA submissions across multiple countries
• Excellent understanding and experience in Regulatory laws, processes, mindset, document requirements, drug labeling requirements, and drug release requirements in multiple European countries

Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“INC Research we’re ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract.

Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Primary Location : Europe - UK Regional
Other Locations : Europe - South Africa, Illovo, Europe - South Africa Regional, Europe - Portugal Regional, Europe - France Regional, Europe - Slovenia Regional, Europe - Spain Regional, Europe - Netherlands Regional, Europe - Serbia, Belgrade, Europe - Russia Regional, Europe - Germany, Munich, Europe - Serbia Regional, Europe - Russia, St Petersburg, Europe - Israel Regional, Europe - Poland Regional, Europe - Hungary, Budapest, Europe - Poland, Warsaw, Europe - Germany, Langenfeld, Europe - Bulgaria, Sofia, Europe - Spain, Barcelona, Europe - UK, Camberley, Europe - Hungary Regional, Europe - Spain, Madrid, Europe - Slovakia Regional, Europe - France, Issy Les Moulineaux, Europe - Israel, Tel Aviv, Europe - Romania, Bucharest, Europe - Czech Republic, Prague, Europe - Romania Regional, Europe - Poland, Krakow, Europe - Scotland, Edinburgh, Europe - Russia, Moscow, Europe - Netherlands, Amsterdam
Job : Site Start Up
Schedule : Full-time
Travel : Yes, 25 % of the Time
Employee Status : Regular