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 : International Associate Regulatory Affairs Director I
Job Description
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 as efficiently and effectively as possible so that no patient waits. A fantastic permanent opportunity has now arisen for an Associate Regulatory Affairs Director I to join our International Regulatory Affairs Management (RAM) team. This role is a unique opportunity to work in a rapidly changing and diverse regulatory environment with other highly specialized and skilled individuals in an area of high importance to the AstraZeneca business. The Associate Regulatory Affairs Director I will focus on providing expert regulatory advice and project management together with strong leadership within the RAM team. They will work collaboratively with International RADs (iRADs) to ensure optimized and accelerated tactical delivery of International market submissions including Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs), and Life Cycle Maintenance (LCM) within an assigned Global Regulatory Execution Team (GRET) in line with International Commercial Priorities.
Accountabilities
- Provide International market regulatory expertise to enable efficient and streamlined tactical delivery of International markets submissions.
- Optimize submission delivery strategies for assigned products/markets including advising on tactical decision-making.
- Communicate and collaborate effectively to remove obstacles from the submission preparation process and support Marketing Companies in rapid filings and responses to HAQs.
- Use and share best practices within the RAM community, role-modeling effective delivery of complex International market submissions.
- Partner with Regional Regulatory Contacts to feedback applied and relevant knowledge and experience gained from International market submissions.
- Support across iRAM to maintain and continuously improve regulatory consistency and achieve “right-first-time” submissions.
- Drive the creation of International shared packs.
- Ensure development and maintenance of key collaborative relationships, alignment of objectives, visibility of issues/risks, and driving issue resolution where necessary.
- Provide subject matter expert input into Regulatory Intelligence initiatives such as the Regulatory Requirements Repository (R3) project.
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverables.
- Lead or contribute to the planning, preparation, and delivery of complex regulatory maintenance submissions from an International market perspective.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Coordinate input, maintenance, and revision in project planning tools for assigned projects, highlighting unforeseen changes in resource demand in a timely manner.
- Identify regulatory risks and communicate mitigations to iRAM Lead and cross-functional teams.
- Support operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management.
- Provide coaching, mentoring, and knowledge sharing within the International regulatory organization.
- Actively seek Continuous Improvement opportunities.
Candidate Profile
- 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, CLEs, license maintenance, and labeling
- Thorough understanding of drug development and International market Regulatory Frameworks
- Thorough knowledge of the regulatory New MAA roll-out and product maintenance process
- Strong project and stakeholder management skills
- Highly developed interpersonal skills, leadership skills, including experience leading multi-disciplinary project teams
- Global working and expert knowledge of International markets
- Proven track record of management of complex regulatory deliverables for International market MAAs, CLEs, and LCM activities across projects/products
- Managed complex regulatory deliverables across projects/products
- 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 : 5++ years
Qualification : University Degree in Science
Location : Bangalore
Job ID : R-211157
Functional Area : Regulatory Affairs
End Date : 20th November 2024
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