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We are recruiting a Director Regulatory Affairs and Quality to a Pharmaceutical company in Stockholm.
The job
You will have the overall responsibility for the management and strategic direction of the RA & QA function within the company. The work will include leading the Regulatory Affairs and Quality Assurance team members, ensuring that operational plans and resources are in-place to deliver objectives. Provide regulatory strategic input and support to the whole, organization, coordinate successful submissions and approvals of all applications and also coordinate and manage external service providers and consultants are daily tasks. We specifically want to point out that this is both a strategic and operational position within the company. You will manage and have responsibility for the RA & QA functional budget and be part of the Management Team.
Your profile
We are seeking a pharmacist, or corresponding, with 8-10 years’ experience within Regulatory Affairs from primarily the pharmaceutical but also medical device industry, You should have experience from regulatory and quality operational activities such as creating regulatory and launch strategies, regulatory submissions, as well as life cycle management from a global or regional perspective. She or he has knowledge of the drug development process all the way to commercialization. You need to have thorough knowledge of the EU regulatory and pharmaceutical legislation and if you also have experience from other regions, such as the US or Japan, this is an advantage. We also see that you have experience from line management involving organizational matters, decision-making and team development.
The right person is innovative, driven and has excellent communication skills. The work tasks also demand a person that has interpersonal, negotiation, analytical, and organizational skills. The applicant must understand the company strategies and business opportunities. The work will include travel and the candidate must have a sense of business acumen with our external partners. You look forward to join a small dynamic company and work in a fast-paced environment
The company, developing and commercializing both Medtech and drug products, is based in Stockholm and you will report to the CEO and play a vital role in the Management Team.
If this looks interesting please contact Herman Krapf, HKR@bondi.se, or mobile 0706-665095.