Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Manager / Senior Manager of Global Regulatory Affairs

Company: PRA Health Sciences
Location: Home or office based, various EMEA locations
Reference: FC 2018 51056
Closing Date: 18 Feb 19
Type: Full Time
Salary (£): Negotiable
Benefits: Excellent

Job Summary:

At PRA we’re optimistic that individually and collectively, we can help make tomorrow better than today. We believe that it is our obligation as a company to help our people find meaningful ways to respond to the needs of others around the world. This sense of common purpose pervades our culture and serves as the foundation of who we are. Explore our career opportunities today and find out how you can be part of it.

Requirements:

Position Overview:

Our business is thriving, and we want you to be a part of it.

We are looking for enthusiastic Regulatory Affairs professionals to grow with our business.  

The Manager of Global Regulatory Affairs plays the pivotal role as a global lead on large global studies, with responsibility for coordinating all Central Ethics Committee (CEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met.?

A highly visible role, our Managers of Global Regulatory Affairs interact daily with other study team members including the clinical team, project management and other functional areas.  This includes communicating the status of submissions to the Start-Up Lead(s) (SULs) and working with them to mitigate risks to Sponsor deliverables.

At this level, you will be a key contact for our clients. You will also be leading and coordinating a team of other (regional) leads within a project and operate at a truly global level.

As a Manager of Global Regulatory Affairs, no two days are the same. Whether it’s meeting with the start-up team, reviewing proposal documents or discussing global submission strategy with a client, you can expect plenty of variety in this fast-paced and active role.

Summary of tasks, including but not limited to: 

  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defence Meetings (BDMs). 
  • Provide the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answer any Sponsor questions surrounding these topics. 
  • Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy. 
  • Prepare the Core Clinical Trial Application and perform QC on the content of all central submission packages. 
  • Preparation of the core Informed Consent Form and co-ordination of the sponsor review of local adaptations.
  • Coordinate a team of Local Regulatory Affairs Leads and/or Global Regulatory Affairs Leads  to ensure contractual timelines are met
  • Keep abreast of current data, including Regulatory knowledge, trends, advances in area of expertise, and developments as they relate to the projects and the department.
  • Contribute to departmental process improvement work streams.

You may also be involved in delivering wider-team training, contributing to departmental or global initiatives, or even managing other dedicated regulatory professionals.

PRA are proud to say that its Global Regulatory Affairs team places great emphasis on personal development via its internal training program; there is plenty of scope to learn and truly forge a long-term career in this department.

You are:

Friendly, proactive and collaborative.

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 bean ambitious regulatory professional with experience of working as a global Regulatory Lead across multiple regions. 

Additional requirements include:

  • An undergraduate degree ideally in science, or health-related field. 
  • A proven track record of leading global regulatory teams
  • Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
  • Expert knowledge of current regional guidelines and regulations, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Read, write and speak English; fluency in host country language required.
  • A team-first approach which fosters positive working relationships with your study team colleagues
  • Fluency in written and spoken English.  

Your health, your family, your career, your money — the things that matter to you, matter to us.

The benefits of PRA just keep getting better and better.

PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace. 

Apply for this job: Manager / Senior Manager of Global Regulatory Affairs

Contact Information:

Address:  Head Office
500 South Oak Way
Green Park
Reading
Berkshire
RG2 6AD
England
Tel:  +44 (118) 918 1000
Fax:  +44 (118) 918 1001
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.