Manager/Senior Manager, Regulatory Affairs - EMEA-150368

Europe, Middle East & Africa-UK-England-Cambridge,
On Application
15 Sep 2018
11 Jan 2019
PPD has opened this fantastic opportunity to join our Regulatory Affairs department as a Manager/Senior Manager, Regulatory Affairs based in the EMEA region.
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. You will also have line management responsibilities for a team of Regulatory Affairs Specialists.
  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. • Line management responsibilities for a team, including recruitment, performance management, training, coaching and mentoring.
• 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.


Education and Experience:    -Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Masters/PhD desirable.
-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.
-CRO/Consulting experience preferred -Strong line management experience required

  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
• English business level language is a requirement

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