Regulatory Country Manager
- Employer
- Barrington James
- Location
- Breda (Gemeente), Noord-Brabant (NL)
- Salary
- €60-90,000
- Start date
- 17 Nov 2022
- Closing date
- 17 Dec 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
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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.
Benefits
- A competitive salary, which is commensurate with experience.
- Generous bonus program, which rewards success. An opportunity to influence global business strategy, and associated implementation.
- A challenging and stimulating position for a dynamic and competent regulatory professional, who wishes to contribute to a growing business and a rapidly expanding team.
- Coaching and mentoring to support your continuous development.
- A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation
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.
Company info
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
United Kingdom
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