Associate Regulatory Affairs Director I (International Regulatory Affairs)

Job Title: Associate Regulatory Affairs Director I (International Regulatory Affairs)

Career Level - E

Introduction to Role:

Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the 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 permanent opportunity has now arisen for an Associate Regulatory Affairs Director I to join our InternationalRegulatory Affairs Management (RAM) team. This role is a unique opportunity to work in a rapidly changing and diverse Regulatory environment with other highly specialised and skilled individuals in an area of high importance to the AZ Business.  The Associate Regulatory Affairs Director I is a highly experienced regulatory specialist who will focus on providing expert Regulatory advice and project management together with strong leadership within the Regulatory Affairs Management (RAM) team in International Regulatory Affairs. They will work collaboratively with International RADs (iRADs) to ensure optimized and accelerated tactical delivery of International market submissions including Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs) and Life Cycle Maintenance (LCM) within an assigned Global Regulatory Execution Team (GRET)  in line with International Commercial Priorities.

The Associate Regulatory Affairs Director I is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager, iRAM Lead or as an iRAM Lead for their allocated projects.  They will partner and collaborate with RAM colleagues in the TA’s to ensure seamless International tactical delivery incorporating Reference country considerations.  They will have an exceptional proven track record working with International markets, 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.   

Regulatory Affairs Management

Contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. Provides regulatory expertise, leadership and guidance on procedural and documentation requirements to International Regulatory Team (IRT) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities:

Regulatory Affairs Management

• Provide International market Regulatory expertise to enable efficient and streamlined tactical delivery of International markets submissions including:Optimisation of submission delivery strategies for assigned products/markets including advising on tactical decision-making

• Effective communication and collaboration to remove obstacles from submission preparation process and support Marketing Companies in rapid filings and responses to HAQs

• Use and sharing of best practice working with Int’l markets within the RAM community and role-modelling effective delivery of complex Int’l market submissions

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

• Provide support across iRAM to maintain and continuously improve regulatory consistency and to achieve “right-first-time” submissions in line with agreed plans and metrics

• Driving creation of International shared packs

• Ensure development and maintenance of key collaborative relationships and ensure alignment of objectives and visibility of issues/risks and driving issue resolution where necessary

• Subject matter expert input into Regulatory Intelligence initiatives eg Regulatory Requirements Repository (R3) project

• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regionsProvides regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

  • Tactical delivery for International submission dossiers for MAA, CLE and LCM applications in all International markets

  • Coordination, review and authoring contribution to HAQ responses and other associated regulatory aintenance documents

• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product

• Uses and shares 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.

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

• Liaises closely with cross-functional members with aligned product responsibilities.

• Develops, executes and maintains submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

• Coordinates 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 and iRAM Lead or as an iRAM Lead to their line manager.

• Identifies regulatory risks and communicate mitigations to iRAM Lead and cross functional teams or as an iRAM Lead to the cross functional teams.

• Supports 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.

• Provides coaching, mentoring and knowledge sharing within the Interational regulatory organisation.

• Actively seeks Continuous Improvement opportunities.

Essential Skills/Experience:

Minimum Requirements – Education and Experience

• Relevant University Degree in Science or related discipline

• Extensive regulatory experience within the biopharmaceutical industry, with 10+ years working with International markets including new MAAs, CLE’s, licence maintenance and labelling

• Thorough understanding of drug development and International market Regulatory FrameworksThorough knowledge of the regulatory New MAA roll-out and product maintenance process

• Strong project and stakeholder management skills

• Highly developed interpersonal skills, leadership skills, including experience leading multi-disciplinary project teams

• Global working and expert knowledge of International markets

• Proven track record of management of complex regulatory deliverables for International market MAA’s, CLE’s and LCM activities across projects/products

Preferred Experience

• Managed complex regulatory deliverables across projects/products

• Experience of working with people from locations outside of India, especially in the International regions

Skills and Capabilities

• Excellent English written and verbal communication skills

• Cultural awareness

• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions

• Proficiency with common project management (eg 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

Internal and External Contacts/Customers

• Global Regulatory Leads (GRLs)

• Regulatory Regional Leads (eg, US, EU, International RADs)

• Lead RPM

• Other R&D skill groups, eg, Global Regulatory Operations, Global Labelling Group,  Operations Regulatory, Patient Safety

• Other internal Science Unit functions within the GMED

• Operations/Manufacturing organisation (CMC post approval)

• Marketing Companies/Local affiliates

• Health Authorities

• External Collaboration partners

Reporting Relationship

• Direct Reports - None

• Indirect Reports -None

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.

Why AstraZeneca?
At AstraZeneca's Biopharmaceuticals R&D division, we believe in turning our drug development strategies into reality. We constructively challenge each other to think of the best approach and influence external Regulators. This means we can drive innovative data to achieve the best possible label. We are a diverse and open-minded team harnessing our different skills and experiences. Our differences enable us to explore new ideas and ways of doing things. It keeps us on our toes and excited for what's next. We are striving for technology adoption and automation to drive efficiencies and new innovations. We believe there's always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.

Ready to make a difference? Apply now and join us in our mission to bring life-changing medicines to patients!

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.