Regulatory Affairs Manager I
Regulatory Affairs Manager I
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Job Description
Job Title: Regulatory Affairs Manager
Introduction to role:
Are you ready to make a difference in the world of medicine As a Regulatory Affairs Manager (RAM) at AstraZeneca youll be at the forefront of transforming breakthrough science into lifealtering solutions. Youll lead the planning coordination and execution of regulatory deliverables contributing to submission strategies and managing applications through approval. Your expertise will guide crossfunctional teams ensuring that our innovative treatments reach patients efficiently and effectively.
Accountabilities:
- Understand the regulatory framework including regional trends for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
- Submission delivery strategy of all dossiers and all application types per market and/or region.
- Review of documents (e.g. response documents study protocols PSRs etc.).
- Analysis of regulatory procedures and special designations used during development authorizations and extension of the product.
- Use and share standard methodologies when handling various applications and procedures during interactions with health authorities and in daytoday 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 products life cycle from either a global and/or regional perspective.
- Develop implement and maintain submission delivery plans submission content plans and proactively provide status updates to designated collaborators.
- 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 crossfunctional teams.
- Support operational and compliance activities for assigned deliverables including generating work requests and submission content plans submission tracking TMF and document management applying 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 field
- 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 multidisciplinary 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
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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca we are driven by science success and achieving our goals through novel approaches. Our inclusive environment fosters collaboration across global teams unlocking regulatory knowledge to bring lifechanging medicines to patients. With a rich pipeline offering exposure to diverse therapy areas youll have opportunities to take on new challenges and drive innovation. Be empowered to be an agent of change in a globally connected business that values learning and sharing best practices.
Ready to make an impact Apply now to join our team!
Date Posted
16May2025Closing Date
22May2025AstraZeneca 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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Manager
Employment Type
Full-Time
