International Regulatory Affairs Manager
About AstraZeneca
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.
About the team We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
About the role:
The Regulatory Affairs Manager in International Regulatory Affairs is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor.
The Regulatory Affairs Manager in International Regulatory Affairs will be responsible for tactical delivery of Int’l Marketing Authorisation Applications (MAAs) and Clinical Line Extensions (CLEs within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager is expected to be able to work flexibly to deliver these accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).
The Regulatory Affairs Manager is fully proficient in applying established standards. Performs Regulatory Affairs Management for highly complex International market submissions under minimal supervision. May facilitate strategic input, capable of leading cross functional activities. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems.
Regulatory Affairs Management Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise and guidance on procedural and documentation requirements for International markets to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Accountabilities/Responsibilities:
Regulatory Affairs Management
Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.- Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
o Contribute to and review of response documents
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
- Liaises closely with cross-functional team members with aligned product responsibilities.
- Develops, executes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Coordinates the input and revision of project plans for assigned projects and highlights unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
- Identifies regulatory risks and propose mitigations to Lead RPM and cross functional teams.
- Supports operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs and/or alliance partners where relevant.
- Provides coaching, mentoring and knowledge sharing on International markets within the regulatory organisation.
- Continuous Improvement mindset Contributes to process improvement.
Minimum Requirements –Education and Experience
Relevant University Degree in Science or related discipline- Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry,
- General knowledge of drug development
- Strong project management skills
- Knowledge of the Regulatory new MAA roll-out process
- Knowledge of International markets in some or all Int’l regions
- Leadership skills, including experience leading multi-disciplinary project teams
- Regulatory affairs experience across a broad range of markets
- Having experience in Regulatory Information Management system (RIM)
- Managed regulatory deliverables at the project level
- 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 (e.g., 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
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.