Senior Regulatory Project Manager (Oncology)
- Experience Level
- Experienced (non-manager)
The CTA Senior Regulatory Project Manager (SRPM) is an experienced regulatory specialist with strong leadership and project management capabilities responsible for leading the end-to-end planning, coordination, and execution of clinical trial related regulatory activities. The SRPM provides regulatory expertise and guidance on procedural and documentation requirements for clinical trial applications (CTAs) to clinical study teams, and other cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. The SRPM also contributes to the efficient operation of the CTA RPM community and takes on delegated responsibilities from group manager.
- Understand, monitor, interpret and validate current and changing regulatory legislation in relation to clinical trials for small and large molecules across all regions and share potential impact these activities may have on the product development program.
- Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for clinical trials
- Use and share 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.
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions related to clinical trials
- Perform regulatory review of clinical trial related documents
- Support operational and compliance activities for assigned deliverables ensuring that all work is performed in accordance with established procedures and regulatory requirements
- Lead GRST & GRET CTA sub-teams
- Identify regulatory risks and communicate mitigations to Lead RPM and cross functional teams.
- Lead continuous improvement work
- Provide coaching, mentoring and knowledge sharing within the RPM skill group.
- Support CTA- RPM group manager in managing the day to day work of the group
- Coordinate resource demand and supply for the CTA RPM and CTA RPA skill group for designated GRET(s) and/or TA as delegated by group manager
- Relevant University Degree in Science or related discipline
- Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
- Thorough Knowledge of drug development
- Strong project management skills
- Strong leadership skills, including experience leading multi-disciplinary project teams
- Excellent written and verbal communication skills
- 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
- Managed complex regulatory deliverables across projects/products
- Knowledge of AZ Business and processes
- Proficiency with common project management (e.g., MS Project) and document management tools
- Global working
- Process improvement