International Associate Regulatory Affairs Director II

Job Title: International Associate Regulatory Affairs Director II

Global Career Level: E

Introduction to role

Within International Regulatory Affairs (inRA), we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AstraZeneca (AZ) pipeline and business to accelerate regulatory approvals for new medicines in international markets as efficiently and effectively as possible so that no patient waits.

A fantastic opportunity has now arisen for a permanent position as an International Associate Regulatory Affairs Director II (iARAD II) to join our International Regulatory Affairs team. This role is a unique opportunity to work in a rapidly changing and diverse regulatory affairs environment with other highly specialized and skilled individuals in an area of high importance to the AZ Business. The advertised iARAD II role is a hybrid ‘International Regional Lead’ and ‘International Regulatory Affairs Management (iRAM) Lead’ role for Established Biopharma Brands, which are the foundation for growth in the International Region.

The iARAD II is expected to be able to work flexibly to deliver varied accountabilities as assigned to them by their line manager. They will partner and collaborate with International & Global colleagues to provide strategic and operational International Regulatory oversight of the growth & life cycle management (LCM) of the assigned Established Biopharma products, to ensure seamless International strategic & tactical delivery. They will have an exceptional proven track record of working with International markets with demonstrated strategic competence, a strong cultural awareness, excellent collaborative skills, advanced problem-solving abilities along with a continuous improvement mindset and a natural ability to effectively coach and mentor.

Accountabilities

In demonstrating International tactical regulatory expertise & strategic competence it is expected that, for Established Biopharma Brands, the iARAD II will perform a hybrid role where they will:

• Lead the International Regulatory Team (IRT), providing strategic and operational regulatory input to the growth & life cycle management (LCM) of the assigned product(s) by serving as the International Regulatory Lead & iRAM Lead to oversee development and delivery of international regulatory strategy & operations (including CMC and non-CMC).

• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of complex regulatory maintenance submissions from an International market perspective.

• Partner with iCMC to monitor the Book of Work for current & upcoming variations to develop the most optimal regulatory strategies aligned with commercial and medical needs.

• In keeping with the global strategy, develop and deliver the International regulatory strategy by driving the planning, coordination & tracking of regulatory submissions for assigned product(s) through effective leadership, project management and regulatory expertise on people, resourcing, procedural and documentation requirements.

• Provide International market Regulatory expertise to enable efficient and streamlined tactical delivery of International markets submissions, for Marketing Authorization Application (MAA), Clinical Line Extension (CLE) and LCM applications.

• Drive optimization of submission delivery strategies for assigned products/markets including advising on tactical decision-making.

• Apply effective communication and collaboration to remove obstacles from submission preparation process and support Marketing Companies in rapid filings and responses to Health Authority Questions (HAQs). Coordinate, review and author contribution to HAQ responses and other associated regulatory maintenance documents.

• Analyze regulatory procedures and special designations used during product development, marketing authorizations and line extension of the product.

• 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 project planning tools for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to their line manager.

• Be an active strategic member of the Global team raising specific gaps, risk and mitigations for International markets around the LCM plan and provide regular updates on International strategy.

• Represent inRA at Global meetings for discussions on International markets strategy and issue resolution on agenda-driven basis, brought in by Global Regulatory Lead (GRL).

• Identify regulatory risks and communicate mitigations to respective stakeholders including GRST/GPT and cross-functional teams.

• Support operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management. May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.

• Use and share best practice ways of working with International markets within the Regulatory Affairs Management (RAM) community and role-modelling effective delivery of complex International market submissions, including Health Authority interactions.

• Partner with the Regional Regulatory Contacts to feedback applied and relevant knowledge and experience gained from International market submissions to facilitate knowledge-sharing.

• Provide support across iRAMs (including coaching & mentoring) to maintain and continuously improve regulatory consistency and to achieve “right-first-time” submissions in line with agreed plans and metrics.

• Ensure development and maintenance of key collaborative relationships and ensure alignment of objectives and visibility of issues/risks and driving issue resolution where necessary. Liaise closely with cross-functional members with aligned product responsibilities.

• Provide subject matter expert input into Regulatory Intelligence initiatives e.g. Regulatory Requirements Repository (R3) project.

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.

• Actively seek Continuous Improvement opportunities.

Essential Skills/Experience

• Relevant University Degree in Science or related discipline

• Extensive regulatory experience within the biopharmaceutical industry, with 12+ years working with International markets and covering all regions predominantly for established products, CLEs, licence maintenance activities, including safety and labelling updates.

• Thorough understanding of drug development and International market Regulatory frameworks.

• Thorough knowledge of the regulatory new MAA roll-out and product maintenance process.

• Strong regulatory strategic skills with project and stakeholder management capabilities.

• Highly developed interpersonal skills, leadership skills, including experience of leading high performing multi-disciplinary teams.

• Proven track record in management of complex regulatory deliverables for International market MAAs, CLEs and LCM activities across projects/products.

• Demonstrate competency in critical thinking, strategic influencing, innovation, initiative, leadership and proficiency with both written and verbal communications.

Desirable Skills/Experience

• Excellent English written and verbal communication skills

• Possess cultural awareness

• Possess strong scientific knowledge to understand regulatory issues and facilitate scientific discussions

• Proficient with common project management (e.g. MS Project) and document management tools

• Able to work independently and as part of a team

• Strong influencing and stakeholder management skills

• Able to analyze problems and recommend actions

• Focused on Continuous Improvement and knowledge sharing

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.

At AstraZeneca, we are part of the solution, turning our drug development strategies into reality. We work at all stages of development to translate our life-changing science into medicines that get the best results for patients in need. Our innovative mindset drives us to think broadly about patients' needs while managing balanced risks. We are valued for our influential work in shaping drug development strategies that lead to fast, efficient approvals. Our diverse team is empowered to make quick decisions while being supported by leaders who remove barriers. We are committed to continuous improvement, always seeking better ways to realize our pipeline.

Ready to make a difference? Apply now!

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.