Regulatory Affairs Manager, Life Cycle Management Uppsala

Do you have experience of working with regulatory affairs? Are you used to working on several different markets at the same time and interested in joining a growing global company with an amazing culture and interesting opportunities? If so, you should keep reading since we are now looking for a Regulatory Affairs Manager to our Uppsala site.

As Regulatory Affairs (RA) manager within Lifecycle Management (LCM) at Galderma in Uppsala, you will be part of a team of ten RA professionals that work with covering all LCM aspects of RA for the portfolio of products at Galderma. You will be responsible for the development of strategies for LCM activities, to assess and ensure implementation of regulatory requirements across many different markets and authorities, and to assess regulatory impact of labeling updates. You are also expected to provide regulatory guidance in general within the Galderma organization.



Responsibilities

You will lead the strategic work for regulatory LCM activities in projects and for specific line activities in close collaboration with Global strategic Marketing, Supply Chain, affiliates and other relevant functions. Specifically, you will take lead in key Regulatory/cross functional project(s). Day to day activities may include:

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Strategic planning and project management of key LCM project(s)
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Providing regulatory expert advice in project and line related activities
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Compiling overall regulatory strategy within LCM projects and line extensions
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Regulatory strategy in connection to labeling and other changes
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Filing and obtaining marketing applications worldwide
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License maintenance activities
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Coordinating compilation of new and updated labeling material
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Compiling, reviewing and approving documentation for regulatory purposes
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Contacting regulatory bodies, affiliates, partners, consultants and distributors
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Tracking of regulatory status and plans within respective product responsibility



Requirements

To be successful in this role you have experience from the field of Regulatory Affairs within Medical Device or the Pharmaceutical industry. Furthermore, you:

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have a university degree within the Pharmaceutical area or similar
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are fluent in Swedish and English, both orally and in writing
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likely have previous experience from project management

You are used to, and enjoy, communication and collaboration both internally and externally with colleagues, authorities and affiliates. You have an engaged, flexible and focused way of working, with the ability to see both the whole picture and the details.



Contact and application

Please apply with CV and cover letter via this page, alternatively via the link Apply now, no later than December 31st. Selection and interviews might be done continuously so do not wait with your application.

If you want to know more about the role you are welcome to contact Talent Acquisition Manager, Marlene Andersson at