OBS! Ansökningsperioden för denna annonsen har
passerat.
Arbetsbeskrivning
CMC REGULATORY AFFAIRS ASSOCIATE, GLOBAL REGULATORY EXCELLENCE
Konsultuppdrag hos AstraZeneca via ALTEN
CMC Regulatory Affairs is a global function that manages all Chemistry, Manufacturing and Controls (CMC) regulatory activities across AstraZeneca’s global supply chain. We are looking for CMC Regulatory Affairs Associates to our product teams for post approval regulatory management located in Södertälje.
We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.
THE ROLE
As a CMC Regulatory Affairs Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by our CMC Regulatory teams.
You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.
You may also support externalisation projects and transfer of CMC documentation to external partners.
MINIMUM REQUIREMENTS - EDUCATION AND EXPERIENCE
Degree in Chemistry or Pharmacy or Chemical Engineering
Fluently spoken and written English and Swedish
Experience in Post Approval Regulatory CMC including CMC documentation authoring
Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
SKILLS AND CAPABILITIES
Able to work collaboratively with customers and colleagues to achieve optimum outcomes
Knowledge of information and document management technology
IT software skills
Ability to work with short and / or changing timelines
Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
Excellent written and verbal communication skills
Experience from using Document Management systems
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
VAD VI ERBJUDER DIG
Varje medarbetare är lika viktig i ALTENs framgång! Vi drivs av att se människor växa och utvecklas, därför skapar vi möjligheter att få arbeta med det man har passion för. På ALTEN har vi ett stort utbud av uppdrag hos flera av de främsta företagen i Sverige i flera olika branscher, där dina önskemål styr din väg framåt. Vi erbjuder såväl nationella som internationella möjligheter och tillsammans med din coachande chef bygger du din karriär så att du kan utvecklas och förverkliga dina mål och drömmar!
Som konsult får du både en teamkänsla i ditt uppdrag och en riktigt härlig gemenskap på ALTEN. Genom våra interna nätverk ALTEN Sports, Women@ALTEN och ALTEN Innovation ges du möjlighet att driva frågor och aktiviteter som just du brinner för, tillsammans med dina kollegor. Allt är självklart frivilligt. Balans mellan arbete och privatliv sätter vi högst på listan. Självklart har vi kollektivavtal. Utöver detta har vi förmåner såsom friskvårdsbidrag, tjänstepension och försäkringar.
WE BELIEVE IN GROWING TOGETHER!
Kontaktpersoner på detta företaget
Pontus Kastrup
Peter Ankréus
+4621349931
Patrik Juhlin
+46214404220
Johan Hägg
Johan Hägg
+46709715805
Andreas Forsberg
+46134655889
Stavros Constantinou
+46134655803
David Kronholm
+46317251131
Ulrika Lin
+46317576133
Erik Rosenqvist
+46317221361