Oasmia is looking for a Regulatory Affairs Director
Oasmia Pharmaceutical AB / Apotekarjobb / Uppsala
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Oasmia develops a new generation of medicinal products within human and veterinary oncology. The product development aims at producing new formulations of well-established cytostatics that, compared with existing alternatives, have improved properties. The product development is based on our own research in nanotechnology and proprietary patents. The company was registered in 1999 and is located in Uppsala. Oasmia is listed on NASDAQ New York, NASDAQ Stockholm and Frankfurt Stock Exchange.
Oasmia Pharmaceutical AB's operations are expanding rapidly. The company produces pharmaceuticals for sale and for clinical trials in its own facility in Uppsala.
The regulatory department currently consists of 5 persons. We are looking for a head of the department.
JOB DESCRIPTION
Major tasks and responsibilities of position:
• Provide leadership and direction to create team spirit and motivation within the Regulatory Affairs Department.
• Responsibility for the budget of Regulatory Affairs within the company.
• Responsible for developing regulatory strategies for international market authorization applications, as well as implementing them.
• Overall Responsibility for SOPs, Strategic Planning, Compilation, Filing and Approval of Product Dossier in accordance with applicable laws and guidelines.
• Facilitate the approval process by identifying possible problems.
• Represents the company as a competent reliable partner to Health Authorities in all regulatory matters.
• Responsibility for cooperation with third parties (CROs) in regulatory matters.
• Responsible for ensuring regulatory compliance within the company.
• Provide regulatory due diligence assessments in cooperation with other departments as required.
• Collaborates with the marketing department regarding strategy and regulatory knowledge.
• You report directly to the CEO.
EXPECTED EDUCATION, EXPERIENCE AND COMPETENCE
Education:
• University degree or equivalent in pharmacy, pharmacology, chemistry or biological sciences.
Experience:
• At least 10 years of experience in Regulatory Affairs within the Pharmaceutical Industry.
• Extensive Leadership experience and you have a good ability to lead others.
• Experience in managing major projects, preferably from headquarters and you have experience from taking a new product from development to approval.
Competence:
• An in-depth understanding of the regulatory obligations both globally and within Europe. Have good knowledge about relevant guidelines and procedures.
• You are a good communicator and have very good language skills in Swedish and English, both in speech and in writing.
• You should have very good computer skills with the Microsoft Office package, Adobe Acrobat and preferably have the experience of working with Microsoft Project 2016
• As a person, you have a business-oriented mindset and a sense for entrepreneurship. You should be good at identifying and solving complex situations.
• Experience within Oncology is preferred merit but not essential.
• As a small company, we put great emphasis on interpersonal skills and are looking for a person that will fit within our team.
The position is permanent and full-time with probation period of 6 months.
The location for the position is at the Oasmia head office at Vallongatan 1, Uppsala.
Selections will be ongoing, please apply with CV as soon as possible, however no later than November 30, 2018. For further information, and in case of questions, please contact Mikael Asp, CEO +18-50 54 40.
When you submit your application, Oasmia will process your personal information, for more information on how these are managed please visit
https://oasmia.com/en/privacy-policy/.Application should be sent to
jobb@oasmia.comPubliceringsdatum2018-11-06Så ansöker duSista dag att ansöka är 2018-11-30
FöretagOASMIA PHARMACEUTICAL AB
KontorsadressVALLONGATAN 1
Jobbnummer 4442675
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