Division Head - Regulatory Affairs

QbD Group 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 30 colleagues in Belgium, the Netherlands, the UK, 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 are accountable for the performance of your team and have P&L responsibility. You feel comfortable in defending our service proposals together with our commercial team and act as the escalation contact for our customers. 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 QbD Group by translating strategic objectives into concrete action plans.
• You are responsible for the realization of the business plan of the RA division, the division's KPI's and P&L (Profit and Loss).
• 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 stay well-informed about the evolution and development related to your division and keep your knowledge up-to-date (e.g. by joining conferences, attending meetups ).
• 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 (e.g. 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 (e.g. assisting HR in interviews with candidates, at job fairs ).
• 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 years of experience within Regulatory Affairs and/or within different business processes, specifically in the services/consulting business.
• 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 ) 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 (e.g. 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 an asset.
• You are based in Europe or in the UK.

What's in it for you?

• QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
• Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
• You will play a pivotal role within one of our divisions, which holds a key strategic focus for our future growth. Your impact in shaping our future is guaranteed.
• As we're a knowledge-based company, you're guaranteed to embark on a continuous journey of learning and development.
• Be part of our global success story. As an award-winning company we value everyone's contribution and celebrate achievements together.

Our promise to you:

• As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
• Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
• In short We 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!