Job title: GPRM/Sr. GPRM (Global Program Regulatory Manager)
Company: The Medicines Company
Job description: Job Description 200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative th
Job Description 200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. The GPRM/ Sr GPRM works independently under limited supervision to provide strategic and operational regulatory direction and may support the DRA global program team (GPT) representative and/or GTAL for programs through development, registration and approval/post approval. The GPRM/ Sr GPRM ensures the execution of regulatory plans in line with global regulatory strategy in close collaboration with the RA global program team (GPT) representative and/or GTAL. In certain cases, the GPRM may be the GPT representative. The GPRM/ Sr GPRM is a member of the DRA sub team and may indirectly report to the DRA GPT representative for the project and has responsibility for leading regional RA sub teams. Your Responsibilities: Your responsibilities include but not are limited to: . 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 . Determines requirements and sets objectives for Health Authority (HA) interactions with RA GPT representative and/or GTAL. . 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. . Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL. 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. . 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. [#video#https://www.youtube-nocookie.com/embed/Mo1vwtVPVA0#400,300##/video#] Minimum requirements What You’ll bring to the role: . Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. 4-6 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred. Involvement in dossier submissions and approvals. HA negotiations Drug regulatory submissions and commercialization in major regions. Proven ability to analyze and interpret efficacy and safety data. Regulatory operational expertise. . Fluency in English as a business language. Additional language is an asset. . Strong knowledge of regulatory submission 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. . Strong interpersonal, communication, negotiation and problem-solving skills. . Organizational awareness (e.g., interrelationship of departments, business priorities). Why consider Novartis 769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 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
Location: Hyderabad, Telangana
Job date: Sat, 29 Jan 2022 23:52:08 GMT
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