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Job Details

Senior Regulatory Affairs Training Manager-138880

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge
Reference: 138880
Closing Date: 18 Sep 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD has opened an exciting new opportunity for Senior Regulatory Affairs Training Manager.  Take your Regulatory Affairs career to the next level in this new role, and lead the Training and Development division of the Regulatory Standards group. ...

Requirements:

PPD has opened an exciting new opportunity for Senior Regulatory Affairs Training Manager.  Take your Regulatory Affairs career to the next level in this new role, and lead the Training and Development division of the Regulatory Standards group.   The purpose of this position is to define, develop, maintain, and implement an effective employee Training and Development programme for the Regulatory Affairs department, and provide primary support for on-boarding new employees and supervisory and operational managerial functions for staff within the Regulatory Affairs.   Primary Responsibilities include:  

  • Identifying, developing, training and tracking of training to all Regulatory Affairs employees
  • Overseeing the lifecycle of training programs from the identification of training needs, content development, updates including version control and change log maintenance
  • Collaborate with departmental subject matter experts in the design of new training materials and updates to existing content
  • Initiate 'Train the Trainer' programme and development materials
  • Represents Regulatory Affairs in internal/external audits
  • Promote training and development capabilities within the department and PPD as appropriate, and provide individual and group training consultation

Qualifications

Education and Experience Requirements   • Bachelor's degree or equivalent and relevant formal academic/ vocational qualification   - Minimum 8 years in Regulatory Affairs

- Minimum of 5 years of training or education experience.

- In some cases, a combination of performance, education and prior directly related experience may be considered as equivalent

to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily   Knowledge, Skills and Abilities Required   • Demonstrates strong knowledge of regulatory affairs and understands its role in the drug development/approval/life cycle process eg: clinical trials support, preparation of marketing authorisations, life cycle management, regulatory intelligence and CMC • Able to define, develop and deliver a variety of RA training and development programs • Has thorough understanding of ICH/GCP guidelines and PPD procedural documents and regulatory requirements • Ability to lead and oversee the planning and logistics of functional training initiatives as needed in an efficient and cost- efficient approach • Demonstrates confident and engaging presentation skills • Advanced skills in using MS Word, Excel, PowerPoint • Excellent written and verbal communication skills  

Apply for this job: Senior Regulatory Affairs Training Manager-138880

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

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