Regulatory Affairs Manager
The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Accountabilities
• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Assigned deliverable(s):
o Submission delivery strategy of all dossiers and all application types per market and/or region.
o Review of documents (e.g. response documents, study protocols, PSRs, etc.).
o Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures in day-to-day work, while operating in a highly dynamic environment.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross-functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement
Essential Skills/Experience
• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams
• Excellent 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
Desirable Skills/Experience
• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of AZ Business and processes
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Work with diverse minds, all united by a shared passion to learn, grow and discover! Join our unrivalled scientific community that fuses academia and industry. We work seamlessly together, playing to each of our strengths, celebrating successes, and learning from the best. Embrace the exposure to build a meaningful career. Internally we are a diverse community with female leaders in 45% of senior roles. Externally we have 475 pre-clinical collaborations in over 26 countries worldwide. In addition, we have established a collaborative research initiative that brings together seven of the world's foremost oncology medical centres to expedite research in some of the hardest-to-treat cancers.
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AstraZeneca 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 authorisation and employment eligibility verification requirements.
