PharmaLex has an exciting new opportunity for a highly motivated and business-minded regulatory professional to work with the Senior Director of its Regulatory Affairs function in the UK.
The successful candidate will have the experience and skills to build on our strong reputation for excellence in Regulatory Affairs. Supporting the Senior Director in the day-to-day activities of the Regulatory Affairs function, the Director of Regulatory Affairs will also contribute expertise to other consultants’ projects as well as undertake hands-on project work where assigned. Line management experience, including an advanced ability to lead, mentor, manage and motivate colleagues, first-class communication skills and a diplomatic, client-orientated manner are essential. The minimum qualification is a degree in a relevant scientific discipline and the ideal candidate will have extensive professional experience in Regulatory Affairs.
This is a pivotal role in the organisation, reporting to the Senior Director of Regulatory Affairs. This is a great opportunity to make a difference in the rewarding environment of a growing business which is part of a successful and forward-looking international group. The position is located in our office in Bourne End, in the heart of the Thames Valley; by the nature of the role, UK and international travel can be expected.
Director, Regulatory Affairs
- Ensuring that Regulatory Affairs projects are delivered to exceptional standards.
- Ensuring that clients’ budgetary expectations are appropriately managed.
- Providing regulatory expertise to regulatory projects being performed by PharmaLex UK and other international offices.
- Interaction with regulatory authorities.
- Line management and recruitment of regulatory staff.
- Co-ordination and planning for the efficient operation of the regulatory affairs service team, including resource planning and pipeline management.
- Accountable to Senior Director, RA/UK country manager for the operational (including employee utilisation) performance of the UK’s regulatory affairs function within budget, as applicable.
- Presenting seminars and lectures to colleagues, customers and other professional audiences.
- Leads/supports the development of corporate commercial materials, white papers and proactively pursues business development opportunities related to the assigned international service area.
- Effective implementation of agreed departmental strategies.
- Accurate time reporting and supervision of accurate time reporting of direct reports.
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Excellent written and verbal communication skills, with a particular focus on client-facing interactions.
- Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.
- At least seven years of experience in pharmaceutical Regulatory Affairs including practical experience in an R&D discipline.
- Several years of experience and broad knowledge in the field of Regulatory submissions of human medicinal products. In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an in-depth understanding of current global and regional trends in Regulatory Affairs.
- Experience in defining and implementation of processes and rules.
- Basic economic knowledge and experience to efficiently and effectively steer the dedicated projects.
- Proficient leadership qualities.
- Capability to analyse problems and to develop possible solutions.
- Capability to motivate employees.
- Capability to professionally represent the department and the company both externally and internally.
- Capability to coordinate different projects to be executed in parallel.
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- A role that is based in an excellent location with good public transport links and close to local amenities.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
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