International Regulatory Affairs Director

The International Regulatory Affairs Director (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 cross-functional 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 cross-functional 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 in-license/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
- Bachelor’s degree in a science-related 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, business-critical, and high-profile development program.
- Successful leadership of major regulatory approval in the International Region.
- Strong cross-cultural 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 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.

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Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.