AstraZeneca contributes meaningfully to the UK beyond the provision of our medicines and the benefits they provide to the health of the nation. We commissioned a report in 2009 to measure our significant investment to the UK economy, which includes investment in jobs and wealth creation. Oxera, an independent economic consultancy provided the analysis for this report.
Post : Associate Regulatory Affairs Director I
Job Description
Accountabilities
As an Associate Regulatory Affairs Director I, you will be a key contributor to regulatory submission strategy, identifying submission risks and opportunities. You will lead regulatory applications and manage procedures through approval. You will also provide regulatory expertise on procedural and documentation requirements to various teams, ensuring the delivery of business objectives. You may also be responsible for the maintenance of global labeling documents for allocated products and the planning and management of Regulatory and basic Clinical and Non-Clinical publishing deliverables.
Candidate Profile
• Relevant University Degree in Science or related discipline
• Minimum 9 years of relevant regulatory experience within the biopharmaceutical industry
• General knowledge of drug development
• Thorough knowledge of the regulatory product maintenance process
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams
• Experience managing complex regulatory deliverables across projects/products
• Experience working with people from locations outside of India, especially Europe and/or USA
• Excellent English written and verbal communication skills
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (eg MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused
Additional Information
Experience : Minimum 9 years
Qualification : University Degree in Science
Location : Bangalore
Job ID : R-210833
Functional Area : Regulatory Affairs
End Date : 30th October 2024
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