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Job Details

Principal Regulatory Affairs Specialist - 12 Month FTC-144224

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge,
Reference: 144224
Closing Date: 22 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD has an exciting new opportunity for a Principal Regulatory Affairs Specialist to join our team on a 12 month fixed term contract.   In this role you will provide regulatory advice and carry out projects in the provision of regulatory affairs services.  You will also act as liaison with internal and external clients in the provision and marketing of regulatory affairs services. ...

Requirements:

PPD has an exciting new opportunity for a Principal Regulatory Affairs Specialist to join our team on a 12 month fixed term contract.

 

In this role you will provide regulatory advice and carry out projects in the provision of regulatory affairs services.  You will also act as liaison with internal and external clients in the provision and marketing of regulatory affairs services. 

 

Responsibilities include but are not limited to:

  • Performing the day to day operational aspects of the department
  • Interfacing with PPD project teams, sponsors and the FDA       
  • Coordinate regulatory submission activities for assigned projects
  • Develop collaborative working relationships with Project Manager and project team members
  • Act as lead and primary liaison between the department, project teams, and the client   

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Qualifications

Education and Experience Requirements:

- Several years of prior regulatory affairs experience and with global understanding of clinical trials

- Ideally candidates will have a degree (or equivalent)

- Knowledge and understanding of ICH and global regulatory guidelines required

 

Knowledge, skills and abilities:

- Strong interpersonal, organizational and planning skills

- Ability to adapt quickly, and lead clinical trial projects

- Ability to confidently perform in client facing role

- Excellent verbal and written communication skills

- Enjoys working in a team setting

- Comfortable working autonomously

Apply for this job: Principal Regulatory Affairs Specialist - 12 Month FTC-144224

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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