Regulatory Affairs Manager I

Job Title: Regulatory Affairs Manager I

Career Level - D

Introduction to role

The Regulatory Affairs Manager I is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role may involve taking on various responsibilities within a Global Regulatory Execution Team (GRET), including Regulatory Affairs Management, Global Labelling Management, and Dossier Management. The Regulatory Affairs Manager I is expected to work flexibly to deliver these varied accountabilities as assigned by their line manager or the Lead Regulatory Project Manager (RPM) for their allocated GRET(s). This role requires proficiency in applying established standards to perform regulatory affairs management for simple to moderately complex products/regions with minimal supervision. The successful candidate will lead cross-functional activities and participate in continuous improvement of processes and tools/systems.

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) including:
• Submission delivery strategy of all dossiers and all application types per market and/or region.
• Review of documents (e.g., response documents, study protocols, regulatory maintenance documents, PSRs, etc.).
• 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.
• Leads and/or contributes to the planning, preparation (including authoring where relevant), and delivery of simple to increasingly more complex regulatory maintenance submissions from either a global and/or regional 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, highlighting unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identifies regulatory risks and proposes mitigations to Lead RPM and cross-functional teams.
• Supports operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, CROs, and/or alliance partners where relevant.
• 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, including labeling history documents.
• Maintains and ensures corporate approval of EU SmPC and US PI and packaging component labeling while ensuring consistency with applicable core labeling documents and internal standards and SOPs.
• Ensures that updates to the core texts are completed, communicated to, and implemented by MCs in a timely manner with agreed deviations documented appropriately.
• Maintains appropriate records for compliance, including repositories of current regional labeling and ensuring proper version control and document integrity of packaging component labeling, printed labeling artworks, and other assigned labeling documents.

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, including publishing and regulatory information management, proposing options to mitigate risks.
• Plans and manages publishing deliverables as well as associated lifecycle and license information.
• Oversees the execution of publishing delivery and responds to arising issues.
• Interprets technical innovation and Health Authority initiatives; communicates regulatory information about products (approvals, license events, market priorities, legacy issues) for GRET.
• Ensures appropriate records are maintained for compliance.

Essential Skills/Experience

• Relevant University Degree in Science or related discipline
• Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling, publishing, and working in regulated markets
• General knowledge of drug development
• 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 working with people from locations outside of India, especially Europe and/or USA

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, you will play a critical role in impacting patients in need. Our science-led enterprise drives fast approvals to get complex products to market quickly. Being part of AstraZeneca means contributing to life-changing medicines for patients with unmet medical needs.

Ready to make a difference? Apply now!

Date Posted

08-Jan-2025

Closing Date

21-Jan-2025

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.