Regulatory Affairs CMC Manager
Galderma / Kemistjobb / Uppsala
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hela Sverige Our global regulatory affairs (RA) department manages new product registrations, line extensions, life cycle management, change control submissions and CMC scientific writing for Galderma?s Aesthetic & Corrective business.
We are now looking for a Regulatory Affairs CMC (Chemistry, Manufacturing & Controls) Manager. This is a permanent position based in Uppsala, reporting to the Group Manager Regulatory Affairs CMC.
About the job
As a member of the RA CMC team you will coordinate Regulatory CMC activities both in product development projects as well as in manufacturing improvement projects. You will also support our Regional/Affiliate organizations with CMC aspects of regulatory submissions for our medical devices.
You will work in close collaboration with several other departments within the company such as Analytical Development.
About your responsibilities
• Marketing applications for new products (CMC related parts)
• Planning, strategy, coordination, review, submission, responses to questions
• Classification of changes
• Reporting requirements
• Regulatory compliance strategies
• Balancing risks and benefits
• Change submissions
• Coordination and writing of submissions and related responses to questions to Regulatory Authorities
• Surveillance of regulatory requirements at Global level
About your education & experience
• You hold a university degree in a life science area such as Chemistry, Pharmaceutical Science or similar
• You have several years of experience from Pharmaceutical and/or Medical Device Regulatory Affairs
• You have several years of experience working within CMC
• Experience from working with China and South East Asia countries is a merit, but not required
About you
• You are open-minded, willing to adapt to differences and enjoy working with others in a collaborative way, also across cultures
• You possess strong communication skills; you enjoy writing and are fluent in English
• You are structured, know how to coordinate the deliveries of others and are able to manage several tasks simultaneously
For further questions please contact:
Maria Edebrink, Group Manager Regulatory Affairs CMC, 0768 98 13 89
To apply please visit
www.galderma.com .
We welcome your application as soon as possible though no later than February 14, 2016.
Varaktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-02-01ErsättningFast månads- vecko- eller timlön
FöretagGalderma
AdressGalderma
75228 UPPSALA
KontorsadressSeminariegatan 21
Övriga kontaktuppgifterTelefonnummer: 018-4749000
Jobbnummer 2645240
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