DirecciónRegulatory Affairs Senior Specialist
Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ 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 Senior Specialist to join our International Regulatory Affairs Management (RAM) team. The Regulatory Affairs Senior Specialist is a regulatory specialist with project management capabilities responsible for supporting the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Senior Specialist in International Regulatory Affairs will be responsible for tactical delivery of Intenational 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 Senior Specialist is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the International Regulatory Affairs Manager Lead (iRAM Lead) for their allocated projects.
The Regulatory Affairs Senior Specialist is fully proficient in applying established standards Performs Regulatory Affairs management for simple/moderately complex International market submissions in all regions with minimal coaching. Provide proactive contribution to submission planning and identify areas for continuous improvement. Participates in 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 to Internatioal Regulaotory Team (IRT) 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:
- 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.
- Contributes to the planning, preparation (including authoring where relevant) and delivery of simple 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 provide status updates to designated stakeholders.
- Coordinates the input, maintenance and revision in the project plannning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to iRAM Lead and Line Manager.
- Identifies regulatory risks and propose 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 .
- Contributes to process improvement.
Minimum Requirements –Education and Experience
- Relevant University Degree in Science or related discipline
- Minimum 4 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
Preferred Experience
- 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,
Skills and Capabilities
- 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
Internal and External Contacts/Customers
- Global Regulatory Leads (GRLs)
- Regulatory Regional Leads (e.g., US, EU, International RADs)
- Lead RPM
- Other R&D skill groups, eg, Global Regulatory Operations, Global Labelling Group, Operations Regulatory, Patient Safety
- Operations/Manufacturing organisation (CMC post approval)
- Marketing Companies/Local affiliates
- Health Authorities
- External collaboration partners
Reporting Relationship
- Direct Reports - None
- Indirect Reports -None
Date Posted
03-abr-2024Closing Date
21-abr-2024AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Regulatory
