PharmaLex has an exciting opportunity for a highly motivated and business-minded regulatory professional to lead its Regulatory Affairs function in the UK as well as have significant international responsibility in the Regulatory Affairs Value Delivery Centre (VDC) through the leadership of an international service area or another prominent international role.
The successful candidate will have the experience and skills to build on our strong reputation for excellence in regulatory affairs. They will demonstrate strong strategic leadership, commercial acumen and budgetary control. Actively leading the day-to-day activities of the regulatory affairs function, the Senior Director of Regulatory Affairs will also contribute expertise to other consultants’ projects as well as undertake hands-on project work where assigned. The Senior Director will also serve as the UK representative in the Regulatory Affairs VDC. For the international dimension to the position, a very strong track record in portfolio maintenance (life cycle management), large global compliance projects or regulatory informatics is desired. 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.
This is a pivotal role in the organisation, reporting to the UK country manager (Managing Director) and the EVP Global Head of Regulatory Affairs or Head of Regulatory Operations (depending on the nature of the international dimension to the role). This is a rare 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.
Senior 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.
- Exemplary 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.
- Responsible for driving business development and marketing activities in the UK across the regulatory service portfolio
- Accountable to UK country manager for the operational (including employee utilisation) performance of the UK’s regulatory affairs function within budget, as applicable.
- Financial departmental responsibilities (generation and reporting) include budgeting and forecasting, the order pipeline and other financial and HR figures
- Accountable to the EVP Global Head of Regulatory Affairs for the leadership of the international service area or the Head of Regulatory Operations for an international RIM responsibility.
- Act as the VDC representative in the local business development (BD) organisation and in the international BD organisation for the assigned service area.
- Representing the UK’s regulatory affairs function within the international PharmaLex organisation.
- Shaping the strategic development of the international service area and the UK’s regulatory affairs department in line with agreed objectives.
- Presenting seminars and lectures to colleagues, customers and other professional audiences.
- Leads 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.
- Minimum qualification is a degree in a relevant scientific discipline
- Extensive professional experience in regulatory affairs.
- Ability to define and convey strategic goals for PharmaLex Regulatory Affairs
- Ability to lead large international and/or complex project teams and
- Ability to balance client requests and company interests
- Ability to analyse and solve problems and to develop pragmatic solutions at higher (e.g. company) level
- Drives solutions to complex problems impacting company success
- Excellent skills in moderating and presentation
- Strategic, analytical and structured thinking and working
- Good ability to impart knowledge and presentation skills
- Ability to manage client relationships on VP level and to convey strategic goals of collaboration
- Convincing and confident appearance, proven capability to communicate critical issues and proposed solutions to senior management levels; ability to convey stakeholders even in critical or sensitive situations
- Ability to adjust rapidly to new, unknown, challenging situations
- Proven track record of achieving targets and driving sales growth in a business
- 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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