Division Head – Regulatory Affairs
il y a 1 semaine
Table of Contents
QbD's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD.
Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a strong international presence with over 50 colleagues in Belgium, the Netherlands, the UK, Switzerland, Spain and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).
As Division Head – Regulatory Affairs your primary responsibility is the further growth of the RA division on an international level. You take responsibility for managing, organising and planning all knowledge activities within the RA division. Furthermore, you are involved in effective resource planning and you act as the single point of contact for the supporting departments and other divisions. In this position you'll report to the Chief Operations Officer.
What do we expect from you as Division Head – Regulatory Affairs?
You are responsible for the establishment of the RA division within the QbD Group, including the realization of the business plan of your division, KPI's and P&L by translating strategic objectives into concrete action plans. You share experience & knowledge and represent the RA division both inside and outside of the organization. You actively collaborate with Business Development for the further expansion of our RA services worldwide. You analyze and explore market trends specific to the company's services that can lead to growth. You give input to our Merging & Acquisition team in case of (international) RA M&A opportunities. You strive for compliance with the other divisions. You identify new opportunities and initiatives within your division and in collaboration with other divisions. You communicate effectively the expectation levels and vision of the company to your division. You encourage, train and mentor the members of your division in a manner that results in high performance and general growth ( you give support on projects, refer to experts in QbD, detect training needs and setup a training program...). You play an active role and support HR in recruiting new members for your division ( assisting HR in interviews with candidates, at job fairs...). You ensure the division is represented outside the company. In general, your responsibilities are 50% outside oriented, 25% internally focused (coaching, training,...) and 25% collaboration with shared services (finance, HR, sales, marketing,...).Who are we looking for?
You combine a master's degree with a scientific background with +10 years of experience in the expertise of your division and/or within different business processes. You can set strategic lines and translate them into concrete objectives, while monitoring P&L, resource planning, sales opportunities and knowledge activities. You are able to oversee how the various business units (pharma, MD, IVD, ATMP, ...), which each consist of strong teams of experts, can improve through cross-fertilisation, while taking into account their specificities. You are a people person with leadership skills who is able to delegate tasks efficiently and empower employees. You are a born networker with commercial feeling and love to take the stage to share your expertise. You lead by example by being flexible and going the extra mile, both literally ( business trips or attending (foreign) conferences) and figuratively. You are a coach for your division members and encourage them to get things done. You are a good communicator who already experienced the importance of a proactive approach and you know how to deal with opposition in a calm and constructive manner. You manage multiple tasks efficiently. You have an entrepreneurial attitude, are stress-resistant, versatile, accurate, autonomous and you think in terms of solutions and take on challenges with a smile. You enjoy working with different nationalities and across different countries. You have excellent verbal and written skills in English. Knowledge of other languages is a true asset. You are based in Europe or in the UK.What's in it for you?
The QbD group is a healthy and international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you the following advantages:
A company with a clear strategy and ambition. You will work in a very dynamic organization (we don't have speed limits) where we expect you to put your own stamp, have impact You are in a flat organization which means short communication lines, easy decision making and well... you won't be shielded from hard work, ambition and some healthy pressure. Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise. You'll work in an award winning company: Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of the year 2019, which means that you'll be part of a vibrant, entrepreneurial organization. We were elected as Best Managed Company by Deloitte in 2020, 2021 and 2022. Working in a value driven and data driven company where a people centric approach and business go hand in hand. We can only put the best of ourselves in our daily work when you also have some fun in the meantime and can build sustainable relationships with your colleagues and partners. We take care of JOY: Trans Alpes Nice Genève with our cycling team, triathlons, (trail) runs, parties and after works, our legendary annual weekend, charity events, ... Get to know your colleagues outside the work environmentIn short... We go and stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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