Job Title: Regulatory Affairs Manager II
Career Level - D
Introduction to role
Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will work flexibly within a Global Regulatory Execution Team (GRET) to manage regulatory affairs, global labeling, and dossier management. This role requires proficiency in applying established standards and the ability to lead cross-functional activities, contributing to the continuous improvement of processes and tools.
Accountabilities
Regulatory Affairs Management
- 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).
- Uses and shares best practices during interactions with health authorities and in day-to-day work.
- Leads and/or contributes to the planning, preparation, and delivery of regulatory maintenance submissions.
- Liaises closely with cross-functional members with aligned product responsibilities.
- Develops, executes, and maintains submission delivery plans and proactively provides status updates to stakeholders.
- Identifies regulatory risks and proposes mitigations to Lead RPM and cross-functional teams.
- Supports operational and compliance activities for assigned deliverables.
- Provides coaching, mentoring, and knowledge sharing within the regulatory organization.
- Contributes to process improvement.
Global Labelling Management
- Maintains core labeling documents including the Core Data Sheet and Core Patient Information Leaflet.
- Ensures consistency with applicable core labeling documents and internal standards.
- Ensures updates to core texts are completed and communicated to Marketing Companies (MCs) in a timely manner.
- Maintains repositories of current regional labeling and ensures proper version control.
Dossier Management
- Contributes proactively to resourcing submission deliverables through liaison with internal Global Regulatory Operations or outsourcing partners.
- Leads the dossier management deliverables for divestment of products.
- Identifies potential regulatory risks to operational plans and proposes options to mitigate risks.
- Plans and manages publishing deliverables, as well as associated lifecycle and license information.
- Develops and maintains strong partnerships with internal and external customers and partners.
Essential Skills/Experience
- Relevant University Degree in Science or related discipline
- Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling, and publishing, and of working in regulated markets
- Thorough knowledge of the regulatory product maintenance process
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
Desirable Skills/Experience
- Regulatory affairs experience across a broad range of markets
- Managed regulatory deliverables at the project level
- Experience of working with people from locations outside of India, especially Europe and/or USA
- 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 take innovative regulatory approaches to bring life-changing treatments to patients. We thrive in an inclusive, diverse, and bold environment where we are empowered to be our best. Our collaborative culture allows us to share learnings and best practices with leading Regulatory specialists across our locations. We are driven by science, success, and achieving our goals in novel ways.
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.