Direct of Regulatory Strategy
- Employer
- RBW Consulting
- Location
- Oxford, Oxfordshire (GB)
- Salary
- Negotiable dependent on experience
- Start date
- 15 Jan 2021
- Closing date
- 14 Feb 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
Job Details
RBW Consulting are collaborating again with one of our UK Pharmaceutical clients. They seek an experienced regulatory affairs strategist to guide them through regulatory frameworks and legislations from Phase I- III.
Working with exciting and innovative treatment methods, this company’s work is currently at early phase and will offer transformational therapy to patients with a range of neurological disorders.
The Strategic Director will be the key stakeholder in the company’s global regulatory activities, working closely with senior management to create and execute regulatory strategy, supported by external agencies.
Prior experience of leading regulatory planning throughout the full life cycle of drug development will be required, and of particular interest is prior exposure to neurological or psychiatric drug development (although this is not essential).
In this role you will provide regulatory leadership and guidance to cross-functional teams, taking responsibility for the preparation, submission and approval of key applications during development. It is also important to keep current on relevant changes in regulatory legislation which may affect development
Requirements
- Relevant life sciences degree
- 15+ years global Regulatory affairs experience (EMEA/EMA, US/FDA etc)- direct experience with CTA submissions
- Evidence of strategic input across all clinical trial phases- able to create strategic roadmap to foresee and negate problems before they arise
- Proven ability to manage external consultants
- Proven track record of effective collaboration with regulatory agencies including the MHRA, EMA, and other European regulatory agencies, ideally also FDA.
- Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive.
- Ability to work independently, to set priorities, meet timelines and to influence other stakeholders.
- Excellent verbal and written communication skills
This role is based in the UK but remote work is on offer. However you must have the ability to travel to the site in Oxfordshire on occasion as required.
If you would like discuss the role in more detail please contact Katie Dunbar on +44 (0)1239 584300 or apply using the button and you will be called back.
If you are not currently looking for a new position, but know someone who would be interested to hear about this role then please do get in touch.
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