International Regulatory Affairs Manager-I

Job Title: International Regulatory Affairs Manager-I

Introduction to role

Are you ready to fuel your ambition and break new ground in the world of regulatory affairs? Within International Regulatory Affairs, we take innovative approaches to bring life-changing medicines to patients across international markets. Our mission is to accelerate regulatory approvals for new medicines efficiently and effectively, ensuring no patient waits. A fantastic permanent opportunity has now arisen for a Regulatory Affairs Manager I to join our International Regulatory Affairs Management (iRAM) team. As a regulatory specialist with project management capabilities, you will lead the end-to-end planning, coordination, and execution of assigned deliverables, including Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs), and Life Cycle Maintenance (LCM). Are you ready to make a difference?

Accountabilities:

- Understands the regulatory framework, including regional or International Market trends, for various types of applications and procedures for small and large molecules across all regions. - Provides regulatory input 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 maintenance documents - Analysis of regulatory procedures/pathways and special designations used during development, authorizations, and extension of the product especially in International space. - 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 provides status updates to designated stakeholders. - Coordinates the input, maintenance, and revision in the project planning tools for assigned projects, and highlights unforeseen changes in resource demand in a timely manner to iRAM Lead and Line Manager. - Identifies regulatory risks and proposes mitigations to iRAM Lead/IRT meetings and as necessary with cross-functional teams. - Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management.

- High efficiency in Regulatory Intelligence, Power BI, Spotfire reports and (Veeva) RIMS management for day to day RAM activities. - Provides coaching, mentoring, and knowledge sharing within the international regulatory organization. - Actively seeks continuous improvement opportunities.

Essential Skills/Experience

- Relevant University Degree in Science or related discipline
- Minimum 8 years of relevant regulatory experience within the biopharmaceutical industry, focusing on international markets including new MAAs, license maintenance, and labeling
- General knowledge of drug development
- Good knowledge of the regulatory New MAA roll-out and product maintenance process
- Strong project management skills
- Knowledge of international markets in some or all international regions.

Desirable Skills/Experience

- Regulatory affairs experience across a broad range of international markets
- Experience in Veeva Regulatory Information Management system (RIM), report generation in applicable tools/Power BI or Regulatory Intel systems
- Experience working with people from locations outside of India, especially in the international regions
- 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 (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

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 driven by results and thrive in our vibrant environment. Our diversity is our strength, reflecting the variety of patients we serve. We strive to create a place where everyone is empowered to speak up and share ideas, welcoming alternative perspectives to push our thinking further together. With opportunities for global mobility, continuous learning, and building best practices, you can unleash your ambition and true self here.

Ready to make your mark? Apply now and be part of our journey to redefine patient care!