Regulatory Affairs Manager
Q-Med Q-Med / Kemistjobb / Uppsala
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Q-Med develops innovative products for aesthetic, corrective and hospital use. In the aesthetic field, Q-Med offers safe, effective and innovative solutions to preserve restore and maintain a healthy and beautiful skin through a complete product portfolio including Emervel, Restylane, Macrolane and Azzalure/Dysport. In March 2011 Q-Med became part of Galderma. Today, the company has over 4 000 employees in 31 affiliates around the world. The state-of-the-art laboratories in France and Sweden together with 4 manufacturing sites are dedicated exclusively to meeting the needs of dermatology patients and physicians. Galderma is present in more than 70 countries throughout the world.
Galderma is a global company delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime. With more than 4,000 employees, Galderma's product portfolio is available in 70 countries and includes prescription drugs, over-the-counter medicines and aesthetic & corrective solutions.
Q-med is Galderma's division specialized in Aesthetic & corrective treatments, and has its global headquarters in Uppsala (Sweden).
We are expanding and now looking for an experienced Regulatory Affairs (RA) Manager to support with regulatory activities at Galderma Nordic. For the right candidate there is a possibility to also work with RA activities at global level for the Aesthetics & Corrective division. This is a permanent contract based in Uppsala and is an ideal opportunity to work in both local and global RA teams.
At local level, the regulatory department is responsible for all regulatory activities in the Nordics, for prescription, OTC and aesthetics & corrective products. At global level, the regulatory affairs department manages new product registrations, line extensions, life cycle, change control submissions and CMC writing for our aesthetic & corrective business.
About the job
We are looking for an experienced regulatory professional to work with the following duties:
• Responsible for all regulatory aspects in the Nordic countries portfolio (prescription, OTC and aesthetics & corrective products)
• Provide regulatory advice on strategies and manage projects
• Responsible for submission of new registrations, variations and renewals
• Act as contact person for regulatory affairs toward other departments at Galderma Nordic, the head office and the Nordic regulatory authorities
• Update of internal processes and working routines within regulatory affairs
• Update of texts on packaging (SPC, PIL, labeling) and different Nordic databases
• **** About you *****
• You have a University degree within the area of Pharmacy, Chemistry or similar.
• You bring relevant RA experience from the pharmaceutical industry and/or Medical Device area
• You have knowledge of regulatory requirements at the Nordic level; experience at global level is an asset.
• You know how to work in an international environment and are able to influence others across cultures and functions
• You possess strong communication skills; fluency in English both verbal and written is required.
• You are flexible and used to taking responsibility, enjoy teamwork and are passionate about RA.
We can offer you a role in a very exciting work environment and growing business with many international contacts. Flexible work arrangements can be discussed for the right candidate.
For further questions please contact:
Sinéad Breen, Global Head of Regulatory Affairs Aesthetic & Corrective: 0768-981230
Please apply for this position as soon as possible though no later than February 18, 2013.
Welcome with your application!
We ask advertising companies or recruitment agencies not to contact us for this recruitment.
Q-Med does not accept unsolicited resumes from staffing companies, including recruitment agencies and / or head hunting companies. Q-Med has a list of preferred partners and pays no fees to companies without a signed agreement. Any recruiter, person or organization that submits a resume to this career site or directly to Q-Med does so with knowledge that the candidate's CV becomes Q-Med's property. Q-Med has the right to hire that applicant at its sole discretion without the sending recruiter, person or organization receiving any fee. Recruitment companies who are Q-Med's preferred partners send CV:s according to agreed routines and data privacy rules.
We wish to inform applicants that Q-Med can conduct pre-employment security checks for specific positions or activities. This security screening is performed by an external supplier after approval from applicants.
Publiceringsdatum2013-01-30Arbetstider och omfattningTillsvidare
ErsättningEnligt avtal
Så ansöker duSista dag att ansöka är 2013-02-18
Ansökan kan tyvärr inte göras via e-post.
Klicka på denna länk för att göra din ansökanKontaktFöretagQ-Med Q-Med
AdressQ-Med Q-Med
Seminariegatan 21
75228 Uppsala
Jobbnummer 1452627
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