Head of Regulatory Affairs - Europe

Location Europe
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: €/£70,000 - £90,000 Per annum
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21729
Published: 22 days ago
Expiry date: 28 June 2021

Location: Europe, Work from Home

I am working on behalf of an international CRO in their search for a Head of Regulatory Affairs. Servicing clients in the Biotech space, my client operate a full-service offering, from medical writing, scientific and statistical consultancy for trial design to regulatory activities and pharmacovigilance.

The Head of Regulatory will manage an international team of six, and be accountable to lead the Regulatory Affairs organization in development and implementation at a global level.

Regulatory Responsibilities

  • Ensures high quality submissions leading to timely approvals

  • Leads and develops a local and global regulatory strategy that is reflective of applicable domestic and international requirement

  • Leads the development and implementation of innovative strategies to maximize the likelihood of regulatory success

  • Leads the oversight and accountability for global regulatory operations

  • Leads and represents regulatory professionals and SMEs

  • Oversees all project related regulatory strategy with all global project teams

  • Assures compliance with project team timelines and milestones for global regulatory deliverables

  • Oversees and is accountable for the effective conduct of formal meetings with regulatory agencies including advisory committee meetings, oral explanations and other scientific and development meetings

  • Leads regulatory strategic development, communication and updates and ensures appropriate consultation and peer review

  • Leads and monitors changes in the regulatory environment (both general and specific to the therapeutic area) and advise department staff accordingly

  • Provides regulatory leadership as needed in early development and due diligence review projects

  • Manages relationships with competent authorities through frequent interaction

  • Collaborates with EU regulatory to develop global approval strategies

  • Provides regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements

  • Maintains up-to-date knowledge of regulatory requirements

  • Represents department/functional area in Business Development, including reviewing proposals and participating in general capability and bid defence meetings

People Management Responsibilities

  • Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project

  • Oversees supervision, development, and mentorship of regulatory personnel

  • Responsible for cultivating a high performing regulatory team focused on accountability and meeting and exceeding expectations

Requirements

  • Scientific Degree

  • At least 5 years of work experience in the field of clinical research

  • Experienced in consultant or CRO environment, with extensive client exposure

  • Strong knowledge of the European regulatory legislation and authorities

  • Knowledge of USA and Asia is considered a plus

  • Knowledge of GCP

  • Able to coordinate regulatory activities, guaranteeing the security of information

  • Good knowledge of English language

  • Able to work independently

  • Good planning and organizational skills

  • Able to manage multiple activities and different priorities simultaneously

  • Able to work independently

  • Able to interact with Sponsors and Competent Authority

This position is based 100% from home, and the ideal candidate will be based in Northern Europe. A generous salary and benefits package is on offer, and this is a great chance to join a stable company with busy workload and interesting client-base.

If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.

Salary: €/£70,000 - £90,000 Per annum