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2017-43704

2017-43704

Title 
Global Submission Manager, Regulatory Operations
Job Locations 
-
United Kingdom
Posted Date 
11/13/2017

More information about this job

Overview

Global Submission Manager, Regulatory Operations

London

 

 

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.

 

Responsibilities

Position overview

 

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:

  • Management of the cross-functional global submission teams in the delivery of compliant submission components according to agreed requirements, timelines and processes.
  • Creation of standard project management tools such as submission risk, issue, escalation and communication plans (as appropriate) for larger/more complex submission types.
  • Identify appropriate submission KPIs in order to track project progress and present to cross functional submission teams.
  • Creates submission work breakdown structures and scheduling plans via the use of network diagrams and GANTT charts. This includes identifying and tracking critical path activities.
  • Create and maintain detailed submission schedules as MS-Project tasks.
  • Encourage process improvement and efficiencies within and across submission project teams.
  • Creation and maintenance of a submission forecast for functional/resource planning, in alignment with the Global Regulatory Plan.

 

Qualifications

 

You are

 

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:

  • Experience working within Global Regulatory Affairs, Regulatory Operations or Project Management environment in pharmaceutical / healthcare industry.
  • Strong working experience of CTA’s, INDs, orphan drug applications (ODA), CTD dossiers for MAAs, national submissions, MRP/DCP and centralized procedures. Including post marketing submissions such as variations, renewals, labeling etc.
  • Fluent with the drug development process and evidence of working with Regulatory Agencies supporting regulatory dossier submission, review and approval processes
  • Solid understanding of project management systems and concepts
  • A Bachelor’s degree (or significant proven experience in a pharmaceutical environment)

 

 

 

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

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