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377274BR Job ID: 377274BR Job Description: 26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs. We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team. Your Responsibilities: Your responsibilities include but not are limited to: • Regulatory Strategy -Responsible for implementing regulatory strategy and managing operational activities for assigned regions.Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.Partners with regions to align on regulatory strategy in order to fulfil business objectives • HA Interactions-Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL. Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents. Develops and implements plans for timely response to HA requests and coordinates responses.Leads HA meetings independently or with RA GPT representative and/or GTAL as appropriate.May serve as local HA liaison depending on location (e.g., FDA or EMA). • Submissions and Approvals -Implements strategy across regions in line with global strategy.Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.Proposes options to minimize risk.Drives coordination, planning, and submission of dossiers in assigned regions worldwide.Review of global dossier summary documents.Develops and implements plans to avoid/minimize clock stops during submission review. • Prescribing Information- Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) with RA GPT representative and/or GTAL, consistent with development data and commercial objectives of the TPP.Generates local PIs, ensuring that they are integrated with the CDS, TPP and regulatory strategy, and are commercially competitive. • Identifies potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.Revises label as needed to achieve timely HA approval with best possible label based on data available. • Regional Excellence and Compliance – Responsible for finalization and on time submission of annual reports and renewals across assigned regions.Responsible for appropriate entering and quality of product specific attributes in compliance database. • Promotional/Non-promotional Review – Reviews promotional and non-promotional materials and press releases as required and work with RA GPT representative and/or GTAL to ensure messages are consistent with Novartis policies and guidelines. • Leadership/Managerial -Provides strategic input and guidance to the MA submissions coordinator and Canada team. Management of approx. 8-12 direct reports . Recruits talents, manages performance (set objectives, review performance and plan compensation), develops associates (development/training plans, Organizational Talent Review, coaching and mentoring)nnnn Position Title: Global Program Regulatory Manager Minimum requirements: What You’ll bring to the role: • Strong knowledge of regulatory submisson and approval processes in 1 or more major regions. • Experience leading regulatory submissions and approvals in at least 1 major region. • Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry • Experience in HA negotiations. Experience or project allocation/project planning for a team • Strong interpersonal, communication, negotiation and problem-solving skills. Organizational awareness (e.g., interrelationship of departments, business priorities). • Fluency in English as a business language. Excellent written and verbal communication skills. • Confident, articulate, and professional speaking abilities (and experience). Empathic listener and persuasive speaker. Excellent presentation and negotiation skills Why consider Novartis? 769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. Imagine what you could do at Novartis! Commitment to Diversity & Inclusion: Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Research & Development Division: Global Drug Development Business Unit: REG AFFAIRS GDD Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
