Global Submission Manager, Regulatory Operations
Who we are
PRA Health Sciences is an award winning CRO.
We are proud to have won Pharma Times 'Clinical Research Company of the Year' in 2017 for the fourth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
As a Global Submissions Manager, you will be dedicated to one of our pharmaceutical clients with a truly global presence; this unique industry-changing partnership redefines collaboration. The program is ideal for individuals who thrive in a continually-evolving culture that mirrors PRA’s commitment to career development.
The Global Submission Manager (GSM) is responsible for the regulatory submissions, aligned directly with the client.
Assigned to global projects the GSM works in collaboration with key members from global and local regulatory affairs providing broad regulatory submission support to plan, monitor and deliver compliant regulatory submissions. The GSM will compile and execute submission strategy plans for new marketing authorisations as well as submission strategies for the maintenance of existing drug licenses across therapeutic areas.
Major tasks and responsibilities of position:
An effective leader with the ability to work at a strategic level. You will have previous experience of working in regulatory operations or regulatory affairs at the forefront of cross functional teams.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com