Associate Director, Regulatory CMC
- Experience Level
- 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
- 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
- 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