Regulatory Affairs Manager Innovation Projects, Galderma

Do you have experience of working with regulatory affairs? From both a product development and Lifecycle management perspective? 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 at Galderma in Uppsala, you will be part of a team of RA professionals that work with covering all aspects of RA for the portfolio of products at Galderma. You will be responsible for the development of Regulatory strategies, to assess and ensure implementation of regulatory requirements across many different markets and authorities, and to assess regulatory impact of Changes. You are also expected to provide regulatory guidance in general within the Galderma organization.

Responsibilities

You will lead the strategic work for regulatory 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/Development/ and other cross functional project(s). Day to day activities may include:

* Strategic planning and project management of key project(s)
* Providing regulatory expert advice in project and line related activities
* Compiling overall regulatory strategy within projects and for line extensions
* Regulatory strategy in connection to CMC (Chemistry, Manufacturing, Control), labeling and other changes
* Filing and obtaining marketing applications worldwide
* License maintenance activities
* Compiling, reviewing and approving documentation for regulatory purposes
* Contacting regulatory bodies, affiliates, partners, consultants and distributors
* 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:

* have a university degree within the Pharmaceutical area or similar
* are fluent in Swedish and English, both orally and in writing
* Likely have CMC experience from similar industries

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

If you are interested, please apply to the role via our digital application system at www.galderma.com/careers, no later than Nov 21st . If you have questions, please contact Talent Acquisition Manager, Marlene Andersson at