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Job Details

Regulatory Affairs Manager - Fluent in French-141066

Company: PPD
Location: Europe, Middle East & Africa-France-Île-de-France
Reference: 141066
Closing Date: 17 Sep 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD has opened this fantastic opportunity to join our Regulatory Affairs department as a Regulatory Affairs Manager.  In this role, you will act as subject matter expert in providing regulatory strategy advice to internal and external clients. ...

Requirements:

PPD has opened this fantastic opportunity to join our Regulatory Affairs department as a Regulatory Affairs Manager. 
In this role, you will act as subject matter expert in providing regulatory strategy advice to internal and external clients. You will lead projects to create and enhance innovative solutions for product development from preclinical through to registration and product optimization, and partners with other departments to collate information in order to secure new business.   Major responsibilities:   Reviews and provides technical advice to prepare regulatory submissions. • Manages project budgeting and forecasting functions. • Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications. • Assists Business Development in pricing and securing new business by making presentations to clients, develops proposal texts and budgets in collaboration with Contracts and Proposal Development. • Matrix manages other individuals assigned to support projects of responsibility. Provides guidance, training, coaching and mentorship to other Regulatory Affairs personnel through liaison with the training manager. Deputizes for functional manager as necessary. • Provides PPD staff with up-to-date legislation and guidance as it becomes available and ensures compliance with relevant organizational and Regulatory Affairs SOPs and WPDs. • Participates in launch meetings, review meetings and project team meetings.

Qualifications

Education and Experience:    -Bachelor's degree or equivalent and relevant formal academic / vocational qualification -Significant experience which provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience. -Solid Regulatory background in global clinical trials.
  Knowledge, Skills and Abilities:   Attention to detail and quality of documentation • Advanced level of skill in Microsoft Excel and PowerPoint for analysis and presentation of data •Excellent organizational and planning skills                                                                                     • Knowledge of budgeting and forecasting •Expert knowledge of regulatory affairs procedures and guidelines for global, regional and national country requirements • Excellent analytical and quantitative skills • Demonstrates executive presence and strong consultation and presentation skills • Experience in influencing at all levels of the organization with ability to act as a liaison with other departments • Ability to multi-task and handle pressure
• French & English business level language is a requirement

Ideally this position will be home or office based in France. We have an office in Paris. Alternatively, we will consider candidates from outside of France who are fluent in French and also have a strong understanding of the Regulatory environment from a Clinical Trials perspective within France.
   

Apply for this job: Regulatory Affairs Manager - Fluent in French-141066

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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