Regulatory CMC Associate Director – Small Molecules

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ReferenceR-004249
Job TitleRegulatory CMC Associate Director – Small Molecules
Job TypePermanent
Job Scope
Business AreaChemistry and Pharmacy
LocationGothenburg, Västra Götaland, Sweden
Salary
Websitehttps://www.astrazeneca.com/
Apply OnlineClick here to apply
Description

At AstraZeneca we believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

The Regulatory CMC (Chemistry, Manufacturing and Control) groups sit within the Global Regulatory Affairs, Patient Safety and Quality Assurance organisation and is accountable for delivering CMC regulatory strategy as well as operational and tactical expertise for drug development projects from Phase 1 through to global launch. Regulatory CMC is a key member of Pharmaceutical Development Project Teams and Global Regulatory Strategy Teams and also works with colleagues in the local marketing companies to ensure successful regulatory approval for clinical and marketing submissions.

We are now looking to recruit a Reg CMC Associate Director to join our team in Gothenburg.

Our stunning campus in Gothenburg is one of AstraZeneca’s three strategic science centres. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve created a series of environments where innovation can happen.

As Reg CMC Associate Director you will:

  • Manage projects for new chemical entities or line extensions as a representative of Regulatory CMC.
  • Contribute to and may lead regulatory CMC components of business related projects across functions.
  • Provide operational, tactical and increasingly strategic regulatory CMC expertise and direction to AstraZeneca project teams.
  • Will be expected to have effective levels of interactive communication within the project team and directly advising and influencing those within the team.
  • Will be expected to manage 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.

Main Duties and Responsibilities

  • Provide regulatory CMC knowledge and progressively increasing levels of expertise. 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.
  • Define the content of CMC submissions and review and approve regulatory CMC documents. Such submissions are clinical trial applications, marketing authorisation applications or line extensions. The applications may be global in scope. May facilitate CMC related interactions with health authorities globally. Member of delivery teams for submissions. Ensure the delivery of submission documentation which is fit for the intended purpose with appropriate consideration of the desire for subsequent operational flexibility.
  • Represent Regulatory CMC on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated.
  • Provide 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 Pharmaceutical Development project team.
  • Establish effective networks with marketing companies, manufacturing sites and relevant technical functions as appropriate for assigned projects.
  • Contribute to knowledge sharing, and provide coaching both within Regulatory CMC and other functions.
  • 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.
  • Carry out main role responsibilities, ensuring compliance with our Corporate Responsibility policies

Essential Requirements

  • 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 of small molecules.
  • Proven 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, will also be considered.
  • Has successfully contributed to regulatory submissions.

For further information regarding this vacancy please contact Per Niklasson in Gothenburg at +46317761403.

Welcome with your application no later than March 30, 2017

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.
 

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OrganisationAstraZeneca
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