Regulatory CMC Director/Associate Director

AstraZeneca   •  

Gaithersburg, MD

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 35 days ago

Description

The Regulatory CMC (Chemistry, Manufacturing & Control) group sits within the CMO organization 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 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 Director/Associate Director to manage complex projects for new chemical entities or line extensions. As a Reg CMC Director/Associate Director you will; -

  • Lead and/or deliver regulatory CMC components of business-related projects.
  • Provide operational, tactical and strategic regulatory CMC expertise and direction to AstraZeneca project teams.
  • Support due diligence reviews.
  • Have a high level of interactive communication skills and cultural sensitivity which you will use to set clear direction for the team and advise and influence others.
  • Manage high level risk by making complex judgements, developing innovative solutions and applying comprehensive cross-functional and industry understanding.
  • Ensure the application of global CMC regulations and guidance within AstraZeneca and lead development of new guidance.

Accountabilities/Responsibilities

  • Provide regulatory CMC expertise to TA and non-TA projects within Medical Affairs and AZ technical functions. Will typically have responsibility for due diligence reviews or 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 on behalf of Medical Affairs for assigned projects. Such submissions are clinical trial applications (IND, CTA, etc.), marketing authorization applications (NDA, MAA, JNDA etc.) or line extensions. The applications may be global in scope. Lead or 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.
  • Represent Regulatory CMC on Regulatory Project Teams for assigned projects to ensure CMC components of the regulatory project are appropriately considered and communicated.
  • 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 Pharmaceutical Development project team.
  • Contribute to or lead policy setting and strategy development in the regulatory CMC environment within or possibly external to AstraZeneca. May lead key business improvement initiatives. May sit on external industry groups.
  • Establish effective networks with marketing companies, manufacturing sites and relevant technical functions such as Pharm Sci or Operations as appropriate for assigned projects. May act as key contact for identified customer Functions to facilitate high quality partnerships with customers.
  • Lead knowledge sharing e.g. be a Focal Point in a Specialist Area, and provide coaching both within Regulatory CMC and Medical Affairs, and possibly to other AZ functions or external to AZ.
  • Ensure that the electronic records in internal documentation systems are accurate and complete, e.g. ANGEL, SLIM and MCM.
  • Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards.
  • Carry out main role responsibilities, ensuring compliance with AZ Corporate Responsibility policies.

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 of small and large molecules.
  • 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.
  • Has knowledge of regulatory submissions in the global environment.
  • Significant project experience in a relevant environment.