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 : Regulatory Affairs Manager II
Job Description
Introduction to role
Within International Regulatory Affairs, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AstraZeneca pipeline and business to accelerate regulatory approvals for new medicines in international markets as efficiently and effectively as possible so that no patient waits.
A fantastic permanent opportunity has now arisen for a Regulatory Affairs Manager II to join our International Regulatory Affairs Management (RAM) team. The Regulatory Affairs Manager II 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 II in International Regulatory Affairs will be responsible for the tactical delivery of international submissions including Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs), and Life Cycle Maintenance (LCM) within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to work flexibly to deliver these varied accountabilities as assigned by their line manager or the International Regulatory Affairs Manager Lead (iRAM Lead) for their allocated projects.
The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools/systems.
Accountabilities
- 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:
* Tactical delivery for international submission dossiers for MAA, CLE, and LCM applications in all international markets
* Coordination, review, and authoring contribution to HAQ responses and other associated regulatory maintenance documents
* 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.
- Leads and/or contributes to the planning, preparation (including authoring where relevant), and delivery of complex regulatory maintenance submissions from an international market perspective.
- Liaises closely with cross-functional members with aligned product responsibilities.
- Develops, executes, and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated stakeholders.
- Coordinates the input, maintenance, and revision in the project planning tools for assigned projects, and highlights unforeseen changes in resource demand in a timely manner to iRAM Lead and Line Manager.
- Identifies regulatory risks and proposes mitigations to iRAM Lead and cross-functional teams.
- Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management.
- Provides coaching, mentoring, and knowledge sharing within the international regulatory organization.
- Actively seeks continuous improvement opportunities.
Candidate Profile
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 labeling
• 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 Skills / Experience
• Regulatory affairs experience across a broad range of international markets
• Experience in Veeva Regulatory Information Management system (RIM)
• Experience 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
Additional Information
Experience : Minimum 8 years
Qualification : Degree in Science or related discipline
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 10-Nov-2024
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