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RA Manager

Introduction


Our client, Qualiphar, a pharmaceutical company that develops, manufactures and markets a wide range of prescription-free medicines and health products, is hiring an experienced Regulatory Affairs Manager that will focus on People Management to strengthen their team.


Company/Department


As a Regulatory Affairs Manager, you have 5 direct reports and you report to the Head of Regulatory Affairs and you are mainly involved in People Management, Leadership, Strategy & Planning and Regulatory Compliance.


Function information


PEOPLE MANAGEMENT

You will have 5 direct reports (4 RA Officer and 1 RA Assistant). You insure the necessary knowledge, skills and attitudes needed to realize the predetermined strategy, objectives and actions.

You manage, coach, monitor and develop your team. By inspiring and motivating them, you favour teamwork.

By being the first point of contact for the team, you make sure that you are approachable and open in your communication. In case of changes you lead and guide them through the process.

Next, you propose and advice on salary adjustments, promotions and dismissals.


LEADERSHIP

You coordinate the performance of the RA department on achieving agreed strategy, objectives and budget by translating the departmental objectives into individual objectives.

It’s your responsibility to provide input to the management regarding the optimal use and follow-up of budgets, necessary investments, the strategy of the RA department and the organization, ...

Furthermore, you are accountable for the organization of the department: staffing, division of tasks, procedures, outsourcing of tests, purchases of office equipment (within the budget), ...


STRATEGY & PLANNING

You are responsible for obtaining and keeping up-to-date regulatory registrations and notifications.

Keeping yourself up-to-date on the legislation and detailed regulatory and scientific guidelines in the concerned countries is a must to advise the RA officers on the execution of complex cases / problems. Either you supervise the execution, or you act yourself.

You determine the regulatory strategy and planning in the (medium) long term in consultation with the Head of Regulatory Affairs.

Together with other departments, BUs and / or management, you discuss feasibility if complex studies / data are requested in the framework of a registration procedure.


REGULATORY COMPLIANCE

It’s your goal to ensure regulatory compliance of all, and especially more complex, documents and processes within the company by analysing and communicating information.

This means that you analyse the impact of changes in the applicable regulations and communicate your recommendations to the management and relevant departments. As well as discussing the regulatory impact of making changes to existing products with the management and other internal and external parties.


Requirements


You have a Scientific master’s degree and profound hands-on experience in Regulatory Affairs and People Management within the pharmaceutical industry.

Having a good awareness of GMP is a must, since the company has a manufacturing site as well.

You have the ability to prioritize and you are highly analytical and detail oriented.

‘Can Do’ is your motto, you demonstrate initiative and you hold a collaborative attitude.

English and Dutch hold no secrets from you and you can effectively and fluently communicate in both languages. Your French doesn’t need to be perfect, but you need at least a good conversational base.


Offer


Qualiphar will directly hire you on their payroll and offer you a full time, permanent contract with a competitive salary, including a car, phone, meal vouchers, pension fund and insurance package.

Furthermore, they offer you the opportunity to grow and develop your career.

You are welcomed within a collaborative and entrepreneurial working environment where’s room for initiative and ownership. There is a family atmosphere, short communication lines and attention to your work-life balance.


Information


-> Not ready to apply or do you have questions first?

Please give me a call on +32 10 80 71 04, I’ll be happy to give you more information!



Astrid Kinoo

astrid.kinoo@xpe-group.net

Permanent Placement eXPErt



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