International Regulatory Affairs Director
International Regulatory Affairs Director
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Job Description
Job Title: Regulatory Affairs Director
Introduction to role
The International Regulatory Affairs Director Markets (IRAD) is responsible for developing and implementing the international regulatory strategy for a group of products. This role ensures that the strategy is designed to achieve rapid approval with advantageous labeling aligning with the product properties and the needs identified by the business markets and patients. The IRAD possesses strategic leadership skills understands regional regulatory science and has extensive knowledge of drug/biologic development processes and strategies. Understanding of the disease area is crucial for crafting crossfunctional discussions with regional and/or Global Product Teams (GPT) and relevant team members. Familiarity with regulatory systems across international markets and a thorough understanding of commercial factors are critical to success in this role.
Accountabilities
Project Regulatory Strategy
Develop and implement innovative international regulatory strategies for a product/group of products ensuring rapid approval with advantageous labeling.
Lead the development communication and updates of the International section of the Regulatory Strategy Document (RSD) for assigned products/projects.
Ensure appropriate crossfunctional coordination particularly with International Commercial peer review and senior team member endorsement from ILT and GPT.
Attain regulatory breakthroughs including evaluating the likelihood of regulatory success and implementing risk mitigation measures.
Objectively assess emerging data against aspirations and update senior management on project risks/mitigation activities.
Leadership
Serve as the single point of contact and Regional Regulatory Affairs representative on Regional Product Teams.
Lead the planning and construction of the International dossier.
Develop and implement an optimal regional (International) regulatory strategy for a product/group of products ensuring rapid market access with advantageous labeling.
Ensure effective regulatory representation at all health authority meetings and clear documentation of discussions and agreements.
Lead regulatory staff working on a product/project to ensure prioritized objectives are delivered on time and with quality.
Participate in skill development coaching and performance feedback of other regulatory staff.
Provide regulatory leadership in product inlicense/due diligence review product divestment and product withdrawal.
Contribute proactively across RAD community and/or Regulatory Excellence objectives and activities.
Regulatory Environment
Partner with marketing company staff to monitor changes in the regulatory environment and support regional and/or Global Product Teams (GPT) or ILT accordingly.
Influence developing views/guidance within leading Health Authorities on specific topics relevant to their project or regulatory more generally.
Essential Skills/Experience
Bachelors degree in a sciencerelated field or equivalent experience.
Previous experience in attending and/or helping a team prepare for Major Health Authority interactions.
Extensive experience or equivalent in regulatory drug development including product approval/launch.
Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
Proven leadership and program management experience.
Ability to think strategically and critically evaluate risks to regulatory activities.
Ability to work strategically within a complex businesscritical and highprofile development program.
Successful leadership of major regulatory approval in the International Region.
Strong crosscultural awareness and ability to work independently with Commercial and Marketing Company colleagues from across the globe.
Must demonstrate proficiencies in critical thinking critical influencing innovation initiative leadership and excellent oral and written communication skills.
Desirable Skills/Experience
Strong commercial awareness.
Subject Matter Expert in International strategy and tactical delivery.
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.
AstraZeneca empowers employees with unprecedented local ownership. We encourage unity and ownership at a local level while fostering collaboration across our global organization. Our diverse community values every voice promoting open communication that leads to powerful innovation. Join us to be part of a team that is bold in setting new directions for patient care bringing transformative drugs to those who need them most.
Ready to make a difference Apply now to join our dynamic team!
Date Posted
07May2025Closing Date
29May2025AstraZeneca 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:
Director
Employment Type
Full-Time
