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.
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
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
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