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Principal Consultant

Employer
Barrington James
Location
Breda (Gemeente), Noord-Brabant (NL)
Salary
€90,000
Start date
17 Nov 2022
Closing date
17 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive
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Job Details

Role

Your main responsibilities will be:

  • Provide Company-wide operational leadership to the project delivery team ensuring timely, high quality on budget delivery of contracted services.
  • Serve a as point of escalation for the global project team, providing timely, accurate feedback and support.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
  • Line manage individual contributors, and in so doing provide on-going coaching and mentoring. Ensure that the project team adhere to processes and procedures.
  • Establish and maintain a high level of technical knowledge in the area of product development and international regulatory affairs.
  • Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts or new business opportunities.
  • Generate additional business from current Clients through exceeding expectations relating to the quality, delivery time and cost of services, and empower others to do the same.
  • Review written estimates, quotations and contracts for Clients as required. Oversee for the company’s Quality Management System.
  • Lead vendor audits and qualification procedures Represent the Company at seminars, conferences and events. To provide strategic, technical and regulatory advice/services to clients in all areas of the development of human medicinal products.
  • Contribute to technical authorship of Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, Clinical Trial Applications, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications
  • Educate clients on current regulatory trends and expectations. Where relevant champion the client's view for development of products with other contractors such as CROs. Represent clients in regulatory agency interactions and providing regulatory solutions to agency objections.
  • Challenge the regulatory ‘status quo’ from a technical and scientific standpoint. Mentoring and training junior members of the consultancy team (including Senior, Consultant and Associate levels)
  • Support the development and operation of the alliance network and new partnership opportunities Provide strategic input/support to Directors and the company's growth plan.
  • Maintain oversight of project budgets.
  • Ensure delivery of project goals within agreed client/team timelines.
  • Support resourcing activities

Essential Skills

  • A high scientific calibre with a life science focused BSc (or equivalent). Ideally the candidate will have post graduate qualifications (MSc, PhD etc).
  • A minimum of 10 years of employment-related experience in regulatory.
  • Proven team leadership abilities in a consulting environment.
  • A professional manner and presentable appearance for meeting customers/clients.
  • Ability to work in a proactive and autonomous manner as well as leading a global team.
  • Ability to balance competing priorities and complete work within a set time-frame.
  • Exemplary organisational skills with a high level of attention to detail.
  • Exemplary verbal communication and presentation skills.
  • High level of computer literacy and competency in MS Office programs.
  • Willingness to work flexible hours and travel for short periods, sometimes at short notice
  • A clean EU driving license
  • RAC/TOPRA accreditation is an advantage.

Company

We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.

Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.

Find Us
Website
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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