Global Program Regulatory Manager- LCM
1 month ago
• 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)
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Dir. Ddit Devit Ra Lcm, Labeling, Mow
4 weeks ago
Hyderabad, Telangana, India Novartis Full time393452BR **Dir. DDIT DevIT RA LCM, Labeling, MoW**: India **About the role** Role Title: Dir. DDIT DevIT RA LCM, Labeling, MoW Location: Hyderabad Role Purpose: - Ensure overall program success and the effective use of resources and within constrains. - Roles and responsibilities: - Establish governance structure for the program with right customer...
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Global Banking
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hyderabad, India Goldman Sachs Full timeThe Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, Global Markets and investment management services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. The firm is headquartered in New York and maintains offices in...
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Global Banking
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Hyderabad, India Goldman Sachs Full timeThe Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, Global Markets and investment management services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. The firm is headquartered in New York and maintains offices in...
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Global Banking
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Hyderabad, India Goldman Sachs Full timeThe Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, Global Markets and investment management services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. The firm is headquartered in New York and maintains offices in...
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Manager, Statistical Programming
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Hyderabad, India Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
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Global Banking
1 month ago
Hyderabad, India Goldman Sachs Full timeThe Goldman Sachs Group, Inc. is a leading global financial services firm providing investment banking, Global Markets and investment management services to a substantial and diversified client base that includes corporations, financial institutions, governments and high-net-worth individuals. The firm is headquartered in New York and maintains offices in...
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Manager, Statistical Programming
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Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Manager, Statistical Programming
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hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Global Banking
4 weeks ago
Hyderabad, India Goldman Sachs Full timeGLOBAL BANKING & MARKETS We make markets in and clear client transactions on major stock, options and futures exchanges worldwide. Through our global sales force, we maintain relationships with our clients, receiving orders and distributing investment research, trading ideas, market information and analysis. OPERATIONS Operations is a dynamic,...
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Global Banking
4 weeks ago
hyderabad, India Goldman Sachs Full timeGLOBAL BANKING & MARKETS We make markets in and clear client transactions on major stock, options and futures exchanges worldwide. Through our global sales force, we maintain relationships with our clients, receiving orders and distributing investment research, trading ideas, market information and analysis. OPERATIONS Operations is a dynamic,...
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Global Banking
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Hyderabad, India Goldman Sachs Full timeGLOBAL BANKING & MARKETS We make markets in and clear client transactions on major stock, options and futures exchanges worldwide. Through our global sales force, we maintain relationships with our clients, receiving orders and distributing investment research, trading ideas, market information and analysis. OPERATIONS Operations is a dynamic,...
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Regulatory Writer
1 month ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
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Hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Specialist, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders and...
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hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Specialist, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders and...
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Program Manager, Global Supplier Diversity
1 month ago
Hyderabad, India Micron Full timeOur vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR50529 Program Manager, Global Supplier Diversity...
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Program Manager, Global Supplier Diversity
1 month ago
hyderabad, India Micron Full timeOur vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR50529 Program Manager, Global Supplier Diversity...
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Expert Regulatory Writer
4 weeks ago
Hyderabad, Telangana, India Novartis Full time392687BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies,...
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Hyderabad, India Micron Full timeOur vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR52582 Director, Global Procurement Program and...
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hyderabad, India Micron Full timeOur vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. JR52582 Director, Global Procurement Program and...
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Hyderabad, India Novartis Full timeJob Summary/Purpose :The Global Associate Director, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders...
