Associate Regulatory Affairs Director I (International Regulatory Affairs)
AstraZeneca
Full time- 10+ years
- Not Disclosed
- Bengaluru, India
- Post Date: Apr 03, 2024
- End Date: Jun 03, 2024
- 10+ years
- Not Disclosed
- Bengaluru, India
- Post Date:Apr 03, 2024
- End Date: Jun 03, 2024
Skills:
- Regulatory Affairs
- Inspection
- Drafting
- Management
Job Description:
Responsibilities
- Provide International market Regulatory expertise to enable efficient and streamlined tactical delivery of International markets submissions including:Optimisation of submission delivery strategies for assigned products/markets including advising on tactical decision-making
- Effective communication and collaboration to remove obstacles from submission preparation process and support Marketing Companies in rapid filings and responses to HAQs
- Use and sharing of best practice working with Int’l markets within the RAM community and role-modelling effective delivery of complex Int’l market submissions
- Partner with the Regional Regulatory Contacts to feedback applied and relevant knowledge and experience gained from Int’l market submissions to facilitate knowledge-sharing
- Provide support across iRAM to maintain and continuously improve regulatory consistency and to achieve “right-first-time” submissions in line with agreed plans and metrics
- Driving creation of International shared packs
- Ensure development and maintenance of key collaborative relationships and ensure alignment of objectives and visibility of issues/risks and driving issue resolution where necessary
- Subject matter expert input into Regulatory Intelligence initiatives eg Regulatory Requirements Repository (R3) project
- Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regionsProvides regulatory expertise 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 aintenance 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 provide status updates to designated stakeholders.
- Coordinates the input, maintenance and revision in the project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to their line manager and iRAM Lead or as an iRAM Lead to their line manager.
- Identifies regulatory risks and communicate mitigations to iRAM Lead and cross functional teams or as an iRAM Lead to the cross functional teams.
- Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management, May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
- Provides coaching, mentoring and knowledge sharing within the Interational regulatory organisation.
- Actively seeks Continuous Improvement opportunities.
Qualification & Experience
- Relevant University Degree in Science or related discipline
- Extensive regulatory experience within the biopharmaceutical industry, with 10+ years working with International markets including new MAAs, CLE’s, licence maintenance and labelling
- Thorough understanding of drug development and International market Regulatory FrameworksThorough knowledge of the regulatory New MAA roll-out and product maintenance process
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Salary
Not Disclosed
-
Role
Associate
-
Area of Practice
- Regulatory Affairs
-
Experience
10+ years
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