AstraZeneca

Associate Director, Regulatory CMC

Location
Maryland, USA, Gaithersburg
Salary
Negotiable
Posted
30 Aug 2019
Closes
27 Sep 2019
Ref
R-060057
Contact
AstraZeneca
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Typical Accountabilities

  • Proactively contribute to the strategy, direction and efficient delivery of drug projects, serving as the reg CMC lead on CMC teams for biological development projects
  • Leads or participates as a member of cross-functional global business projects, providing expert regulatory advice
  • Provide timely, constructive feedback to AZ colleagues
  • Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex CMC submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Participates as a member of cross-functional Global Regulatory Strategy teams for drug projects, providing expert regulatory CMC advice and collaborating with therapeutic area regulatory counterparts
  • Identifies and communicates potential complex regulatory CMC risks to the global and regional operational plans identifies regulatory CMC risks and propose options to mitigate risks.
  • Provides regulatory CMC expertise on global and regional regulatory submissions, health authority briefing documents and response documents.
  • Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Essential

  • Bachelor's Degree in Science or related discipline, advanced degree a plus
  • Significant experience of working in one or more areas in regulatory affairs in the biopharmaceutical industry, or in regulatory drug development, product approval/launch, line extension and licence maintenance, or experience at a health authority
  • At least 4 years of regulatory CMC experience a plus
  • Project and process management skills

Desirable

  • Regulatory experience across global projects and several regions
  • Works collaboratively - respects and integrates diverse views into decisions/proposals
  • Problem solving skills
  • Focus on delivery and results
  • Ability to work in a complex, business critical and high-profile environment

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