Regulatory Affairs Manager II
2 weeks ago
Job Title: Regulatory Affairs Manager II
Career Level - D
Introduction to Role:
Join our International Regulatory Affairs team at AstraZeneca, where we are committed to bringing life-changing medicines to patients in international markets as efficiently and effectively as possible. We have an exciting opportunity for a Regulatory Affairs Manager II to join our team. This role is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will be expected to work flexibly to deliver these varied accountabilities as assigned to you by your line manager or by the International Regulatory Affairs Manager Lead (iRAM Lead) for your allocated projects.
Accountabilities :
As a Regulatory Affairs Manager II, you will understand the regulatory framework for various types of applications and procedures for small and large molecules across all regions. You will provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s). You will also lead and/or contribute to the planning, preparation, and delivery of complex regulatory maintenance submissions from an International market perspective. You will develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. You will also identify regulatory risks and propose mitigations to iRAM Lead and cross-functional teams.
Essential Skills/Experience:
- Relevant University Degree in Science or related discipline
- Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, focusing on International markets including new MAAs, license maintenance and labelling
- General knowledge of drug development
- Good knowledge of the regulatory New MAA roll-out and product maintenance process
- Strong project management skills
- Knowledge of International markets in some or all International regions
Desirable
- Regulatory affairs experience across a broad range of International markets
- Experience in Veeva Regulatory Information Management system (RIM)
- Experience of working with people from locations outside of India, especially in the International regions
- Excellent English written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (, 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
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are committed to turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need, and healthcare professionals. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are striving for technology adoption and automation to drive efficiencies and new innovations. We believe there's always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things, and sharing new proposals.
Are you ready to bring your unique perspective to help shape our future? Apply now to join our Biopharmaceuticals R&D team and be part of the solution
Date Posted
04-Jun-2024Closing Date
04-Jun-2024-
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