Job Title: Regulatory Affairs Manager II
Career Level - D
Introduction to role
Within International Regulatory Affairs, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AstraZeneca 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 a Regulatory Affairs Manager II to join our International Regulatory Affairs Management (RAM) team. The Regulatory Affairs Manager II is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an individual contributor. The Regulatory Affairs Manager II in International Regulatory Affairs will be responsible for the tactical delivery of international submissions including Marketing Authorisation Applications (MAAs), Clinical Line Extensions (CLEs), and Life Cycle Maintenance (LCM) within an assigned Global Regulatory Execution Team (GRET). The Regulatory Affairs Manager II is expected to work flexibly to deliver these varied accountabilities as assigned by their line manager or the International Regulatory Affairs Manager Lead (iRAM Lead) for their allocated projects.
The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools/systems.
Accountabilities
- Understands the regulatory framework, including regional 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 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 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 and cross-functional teams.
- Supports operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management.
- 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)
- 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 bring hope and solutions to patients with unmet needs across the globe. As regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Here we thrive in our inclusive, diverse, and bold environment. We draw on our diverse knowledge to take smart risks and uncover new ways to deliver better for our patients and our business.
Ready to make a difference? Apply now!
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.