Regulatory Affairs CMC Manager
Galderma / Kemiingenjörsjobb / Uppsala
2016-01-18
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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 temporary 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, Product Development, Stability, Microbiology and Sterility Development and Industrial 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 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 experience from Pharmaceutical and/or Medical Device Regulatory Affairs
• You have several years of experience working within CMC
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.
About Galderma
Galderma is a global company delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime. With more than 5,500 employees, Galderma has three units focusing on prescription drugs, self-medication medicines, and aesthetic & corrective solutions.
Galderma Uppsala is Galderma?s global center of excellence for Aesthetic & Corrective, and has state-of-the-art research, development and manufacturing activities. Here our 450 employees discover, produce and commercialize our solutions worldwide, focusing on to leading brands such as Restylane, Emervel, Azzalure and Pliagils.
Varaktighet, arbetstid
Visstidsanställning 6 månader eller längre
Heltid
Publiceringsdatum2016-01-18ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-02-14
Ansök via vår hemsida:
Klicka på denna länk för att göra din ansökanAnge följande referens när du ansöker: 201604
KontaktMaria Edebrink Enström, Groupe Manager Regulatory Affairs 0768 98 13 89 (Mobil)
maria.edebrink@galderma.comFöretagGalderma
AdressGalderma
75228 UPPSALA
KontorsadressSeminariegatan 21
Övriga kontaktuppgifterTelefonnummer: 018-4749000
Jobbnummer 2621265
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