Group Manager Global Regulatory Affairs
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.
Q-Med is a global leader in aesthetic and corrective treatments. With global headquarters located in Uppsala (Sweden), Q-Med is a division of Galderma, one of the world's leading dermatology companies.
The Regulatory Affairs department is responsible for all regulatory aspects of our business, including new product registrations, line extensions, life cycle management, change control submissions and CMC writing at global level.
We are expanding and now looking for a Group Manager to lead the team working on all aspects of the medical device product line. You will report to the Head of Regulatory Affairs for the Aesthetics & Corrective division.
About the job
We are looking for an experienced regulatory professional to lead and implement our regulatory strategies at global level and provide regulatory support for the registration and post-licensing activities of our medical device products. Your will be responsible for:
• Leading the Regulatory Affairs team, including international submissions, interactions with regulating bodies, and international product registration and re-registrations.
• Working strategically and business orientated in order to develop strategies for rapid product approval and timely market entry
• Driving the Regulatory Affairs team forward in order to reach the overall objectives set for the organization.
• Managing staff (7 direct reports) and budget
• Working cross functionally with R&D, marketing, production and regulatory staff at global or local levels.
About you
• You have a University degree within the area of Pharmacy, Chemistry or similar.
• You bring relevant experience from Regulatory Affairs from the pharmaceutical industry, preferably from the Medical Device area. You have a broad experience of the regulatory work; knowledge of clinical development can be a plus.
• You know how to work in an international environment and have experience at global level working with local affiliates.
• You have strong organizational and planning skills with the ability to lead projects within tight time frames and to prioritise.
• You are an experienced leader (3 to 5 years management experience) with demonstrated leadership abilities
• You possess strong communication skills and are able to influence others across cultures and functions. Fluency in English both verbal and written is a must.
• You are flexible and used to taking responsibility, enjoy teamwork and are passionate about Regulatory Affairs.
We can offer you a role in a very exciting work environment and growing business with many international contacts. Flexible work arrangements can be offered for the right candidate.
For further questions please contact:
Sinéad Breen, Head of Regulatory Affairs: 0768-981230
Apply for this position as soon as possible though no later than February 4, 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.
Publiceringsdatum2013-01-16Arbetstider och omfattningTillsvidare
ErsättningEnligt avtal
Så ansöker duSista dag att ansöka är 2013-02-04
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 1438884
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