CMC (Chemistry Manufacturing and Control) Associate Director at
Dfind Engineering / Apotekarjobb / Göteborg
2014-07-19
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We are now looking for a CMC Associate Director for a 11 moths assignment starting as soon as possible. You will manage projects for new chemical entities or line extensions as a representative of Regulatory CMC. In this role you will contribute to and may lead regulatory CMC components of business related projects.
Business: Dfind Science & Engineering
City: Göteborg
You will provide operational, tactical and increasingly strategic regulatory CMC expertise and direction to AstraZeneca project teams. We expect the successful candidate to have effective levels of interactive communication within the project team and directly advising and influencing those within the team.
You will responsible for managing risk using evaluative judgements in complicated or novel situations, ensure the application of global CMC regulations and guidance within AstraZeneca and contribute to development of new guidance.
Accountabilities/Responsibilities:
1. Provide regulatory CMC knowledge and progressively increasing levels of expertise to TA and non-TA projects within AZRA and AZ technical functions. Will typically have responsibility for development projects for new chemical entities or line extensions. Ensure project activities are delivered to a high standard, agreed time scales and meet AZ business requirements, compliance requirements and regulatory authority expectations worldwide.
2. Define the content of CMC submissions and review and approve regulatory CMC documents on behalf of AZRA for assigned projects. Such submissions are clinical trial applications (IND, CTA, etc), marketing authorisation applications (NDA, MAA, JNDA etc) or line extensions. The applications may be global in scope. May facilitate CMC related interactions with health authorities globally. Lead CMC submission management team. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
3. Represent Regulatory CMC on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated.
4. Provide AZ technical functions clear, concise guidance on current CMC regulatory requirements to support business tactical or strategic planning. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation. Member of a PAR&D or PR&D project team.
5. Establish effective networks with marketing companies and relevant technical functions such as PR&D, PAR&D or Operations as appropriate for assigned projects.
6. Contribute to knowledge sharing, e.g. be a Focal Point in a Specialist Area, and provide coaching both within Regulatory CMC and AZRA.
7. Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. GEL, SLIM and MCM.
8. Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards.
Minimum Requirements -Education and Experience
• Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science.
• A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture.
• Typically six years experience in Regulatory Affairs, with focus on CMC. Other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture, might also be considered.
• Has successfully contributed to regulatory submissions.
Skills and Capabilities
• Good written and spoken English.
• User-level skills in computers and data bases.
• Project management skills.
• A broad understanding of regulatory application procedures and worldwide regulatory CMC requirements for development, license maintenance and renewal submissions.
• A strong understanding of the regulatory affairs function and customer functions and business processes and how they contribute to achieving the overall objectives of AstraZeneca.
• Leadership capabilities:
• Understands, identifies and manages risks.
• Takes responsibility for actions and results and encourages others to do the same.
• Strives to improve cross-functional work and eliminates activities that do not create value.
• Engages others through active and clear communication.
• Shows confidence in the ability of the team even during periods of adversity.
• Problem solving: Evaluative judgements based on the in-depth analysis of factual and qualitative information in complicated or novel situations. Requires developed conceptual thinking. Dealing with ambiguity in a range of situations.
• Professional and effective levels of interactive communication skills are required in order to negotiate and influence others, as well as cultural sensitivity.
Organizational Behaviours
• Customer focused:
• Awareness and understanding of customer's needs and can meet them.
• Performance driven:
• Working according to AstraZeneca's business norms and ethics.
• Finding creative solutions to deliver results more effectively and with better quality.
• Teams passionate about winning:
• Can see things from several perspectives and uses the ability, knowledge and experience that the team possess.
Internal and External Contacts/Customers
• Regulatory Project Teams
• Operations project teams
• Marketing company regulatory groups
• Health authority regulatory agency staff
Deadline for applications: 2014-07-28
More information: Camilla Bågenholm 0733 434777.
Organization/Business description:
Dfind Science & Engineering är ett konsult- och rekryteringsföretag specialiserade på kompetenser inom naturvetenskap och teknik. Med engagemang och lyhördhet hjälper vi människor och företag att hitta lösningar för att utvecklas. Hos oss har du möjlighet att utveckla dina kunskaper och färdigheter genom uppdrag hos våra utvecklings- forsknings- och produktionsintensiva kunder i Norden.
Vi tycker att det är viktigt att all kompetens på arbetsmarknaden tillvaratas. Vi välkomnar alla sökande och eftersträvar mångfald. Dfind Science & Engineering ett auktoriserat bemanningsföretag via Almega och följer deras kollektivavtal.
Publiceringsdatum2014-07-19Arbetstider och omfattningHeltid Visstid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2014-07-28
Ange följande referens när du ansöker: 200616904
Klicka på denna länk för att göra din ansökanKontaktCamilla Bågenholm
camilla.bagenholm@dfind.seFöretagDfind Engineering
AdressDfind Engineering
Östra Hamngatan 23
41110 GÖTEBORG
KontorsadressÖstra Hamngatan 23, 41110 GÖTEBORG
Jobbnummer 1942331
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