Regulatory CMC Director - New Modalities
AstraZeneca / Elektronikjobb / Göteborg
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AstraZeneca is looking to recruit a Regulatory CMC Director with experience of small molecule development to join our Regulatory CMC group in Gothenburg. This is an exciting opportunity to drive innovative regulatory strategies to support a range of new chemical entities and novel products, including devices and new modalities, across a range of therapeutic areas. Regulatory CMC is part of Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) and delivers CMC regulatory strategy and operational and tactical expertise for drug development projects from Phase 1 through to global launch. Regulatory CMC Directors are a core member of Global Regulatory Strategy Teams and Pharmaceutical Project Teams and work closely with colleagues in AZ marketing companies across the globe to ensure successful regulatory approvals for clinical trial and marketing applications.
As a Reg CMC Director you will:
* Provide strategic, tactical and operational expertise and direction to AstraZeneca project teams, based on understanding of global CMC regulations
* Manage high level risk by making complex judgments, developing innovative solutions and applying comprehensive cross-functional and industry understanding.
* Have a high level of interactive communication skills and cultural sensitivity which you will use to advise CMC teams on how to achieve successful regulatory outcomes.
* Lead project driven regulatory interactions with health authorities, e.g. FDA, EMA, for CMC scientific advice.
* Lead and/or deliver regulatory CMC components of business process improvement projects.
* Ensure the application of global CMC regulations and guidance within AstraZeneca and lead development of new guidance.
* You may also be asked to support due diligence reviews.
Accountabilities & Responsibilities
* Ensure CMC components of the regulatory project are appropriately considered and communicated.
* Represent Regulatory CMC on Global Regulatory Strategy Teams and Pharmaceutical Project Teams and provide regulatory CMC advice to new chemical entities or line extensions across multiple therapy areas.
* Ensure project activities are delivered to a high standard and agreed time scales whilst meeting AZ and worldwide health authority requirements and standards.
* Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.
* Define the content required for CMC submissions for assigned projects and review and approve regulatory CMC documents ('ND, CTA, MAA, NDA, JNDA etc) on behalf of GRAPSQA. The applications may be global in scope.
* Ensure that marketing submissions are fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
* Lead or facilitate CMC related interactions with health authorities globally.
* Contribute to policy setting and strategy development in the regulatory CMC environment within or possibly external to AstraZeneca. May lead key business improvement initiatives or sit on external industry groups.
* Establish effective networks with marketing companies, manufacturing sites and relevant technical functions as appropriate for assigned projects.
* Undertake effective knowledge sharing within the Regulatory CMC group, e.g. lead a specialist focus area, or coach others.
* Ensure that the electronic records in internal documentation systems are accurate and complete.
* Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards.
Minimum Requirements
* Experienced graduate or PhD in a scientific discipline, typically chemistry, pharmacy or a biological science.
* Proven experience in Regulatory Affairs, with focus on CMC or other relevant experience in the pharmaceutical industry, for example in Pharmaceutical or Analytical Development, Quality Control, Manufacture.
* A significant knowledge and understanding of the science and technology associated with pharmaceutical development and manufacture of small and large molecules.
* Has successfully contributed to at least one major regulatory submission in the global environment.
If you are interested, please apply now!
For more information about the position please contact Per Niklasson,
Welcome with your application no later than March 3rd, 2019.
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-02-18ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-03-04
Ange följande referens när du ansöker: R-044919
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
sara.jagevall@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 4619752
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