Job Description

JOB TITLE: Regulatory Affairs Manager I

CAREER LEVEL: D

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world\xe2\x80\x99s most serious disease. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s leading pharmaceutical companies. At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work.

ABOUT OUR R&D TEAM

Be part of the team where you are empowered to follow the science. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals. There are countless opportunities to learn and grow. You will have the opportunity to shape your own path, with support all the way. We are a diverse and open-minded team harnessing our different skills and experiences.

ABOUT THE 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, including delivery as an individual contributor, if required. The Regulatory Affairs Manager I may tackle the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Affairs Management andGlobal Labelling Management The Regulatory Affairs Manager I is expected to be able to work flexibly to deliver these varied accountabilities as assigned to them by their line manager or by the Lead Regulatory Project Manager (RPM) for their allocated GRET(s).

The Regulatory Affairs Manager I is fully proficient in applying established standards to perform regulatory affairs management for simple/moderately complex products/regions and under minimal supervision. Capable of leading cross functional activities. Participates continuous improvement of process and tools/systems.

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 and guidance on procedural and documentation requirements to GRET, Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Global Labelling Management

Provides regulatory labeling expertise and leads the maintenance of global labeling documents for allocated products. Is responsible for the regulatory activities involved in the coordination, development and implementation of revised printed labeling for allocated products, including USPIs and other regional labeling.

Accountabilities/Responsibilities:

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:

Description

Submission delivery strategy of all dossiers including established brands and all application types per market and /or region including Divestments, Marketing authorization transfer (MAT) and withdrawals.

Provide scientific contribution to single documents such as PSRs, response documents, study protocols, regulatory maintenance documents Risk Management Plans, Periodic Safety Update Reports, Addendum to Clinical and NonClinical Overview, Pharmacovigilance agreement (PVA), Core labelling documentation (e.g. Company Core Data Sheets, USPI, EUQRD and Core Safety Profiles), 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, while operating in a highly dynamic environment.

Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective like INDs, CTAs, EU PIP, Briefing document, scientific advice, Investigational brochure (IB), Target product profile (TPP), MAAs, NDAs, CSRs, CSP.

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

Develops, completes and maintains submission delivery plans, submission content plans using digital tools like Veeva Vault (ERV) and compliance, and proactively provides status updates to designated collaborators.

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 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 applying 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 organisation.

Chips in to process improvement.

Global Labelling Management

This will include:

the maintenance of core labeling documents including the Core Data Sheet, and Core Patient Information Leaflet, including labelling history documents.

the maintenance and 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.

Description

Ensuring that updates to the core texts are completed, communicated to and implemented by MCs in a timely manner and deviations are agreed and documented appropriately.

Ensures that appropriate, up-to-date records are maintained for compliance, including maintaining 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,.

Minimum Requirements \xe2\x80\x93Education and Experience

Relevant University Degree in Science or related field

Minimum 6 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling and publishing, and of 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.

Preferred Experience

Regulatory affairs experience across a broad range of markets

Handled regulatory results at the project level

Knowledge of Veeva vault (ERV) for submission, compilation, publishing and approval processes, standards, systems and CTIS tools.

Experience of working with people from locations outside of India, especially Europe and/or USA.

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 (e.g., MS Project) and document management tools

Basic understanding of emerging technologies like AI, ML etc

Demonstrate ability to use digital tools and solutions relevant to own work tasks to support productivity, collaboration and learning

Work proactively to understand future needs and opportunities for digital transformation that improve the effectiveness and speed of core business processes and decision making.

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.

WHY JOIN US?

We\xe2\x80\x99re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We\xe2\x80\x99re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it\xe2\x80\x99s because we make a significant impact. Everything we do matters.

SO, WHAT\xe2\x80\x99S NEXT?

Are you already envisioning yourself joining our team? Good, because we\xe2\x80\x99d love to hear from you! Click the link to apply and we\xe2\x80\x99ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

Date Posted 09-Feb-2024

Closing Date 16-Feb-2024

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.

AstraZeneca