Global Program Regulatory Manager- LCM
2 weeks ago
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.
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.
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.
- Regional Excellence and Compliance - Responsible for finalization and on time submission of annual reports and renewals across assigned regions.
- 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)
-
Senior Manager, Global Regulatory Sciences-CMC
2 weeks ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeDescription The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a product's lifecycle. Members of the organization develop global regulatory CMC strategies and partner with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for...
-
Associate Director, Global Regulatory Sciences
2 weeks ago
Hyderabad, Telangana, 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...
-
Senior Manager I-Global Regulatory Sciences-CMC
1 month ago
Hyderabad, Telangana, 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...
-
Senior Manager I-Global Regulatory Sciences-CMC
2 weeks ago
Hyderabad, Telangana, 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...
-
Senior Manager I-Global Regulatory Sciences-CMC
4 weeks ago
Hyderabad, Telangana, 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...
-
Manager, Statistical Programming
2 weeks ago
Hyderabad, Telangana, 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 the...
-
Associate Director, Global Regulatory Sciences
1 month ago
Hyderabad, Telangana, 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...
-
Associate Director, Global Regulatory Sciences
4 weeks ago
Hyderabad, Telangana, 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...
-
Regulatory Writer
2 weeks 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 to...
-
global procurement program manager
2 weeks ago
Hyderabad, Telangana, 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. JR52680 GLOBAL PROCUREMENT PROGRAM MANAGER The ...
-
Hyderabad, Telangana, 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...
-
Hyderabad, Telangana, 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...
-
Associate Director, Global Regulatory Sciences
2 weeks ago
Hyderabad, Telangana, 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...
-
Program Manager- Global Planning
2 weeks ago
Hyderabad, Telangana, India Amazon Dev Center India - Hyderabad - A85 Full timeJob Description At Amazon, we're working to be the most customer-centric company on earth. To get there, we need exceptionally talented, bright, and driven people. Our mission in CTPS is to make the safest place to shop online. The CTPS team safeguards the order pipelines; monitoring, tracking, and managing risk to ensure long-term buyer satisfaction. As...
-
Program Manager, Global Supplier Diversity
2 weeks ago
Hyderabad, Telangana, 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...
-
Regulatory Coordinator
2 weeks ago
Hyderabad, Telangana, India Novartis Full time26 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...
-
Global Banking
2 weeks ago
Hyderabad, Telangana, 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,...
-
Global Banking
2 weeks ago
Hyderabad, Telangana, 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...
-
Regulatory Coordinator
2 weeks ago
Hyderabad, Telangana, India Novartis Full time387033BRRegulatory Coordinator:IndiaAbout the roleYour responsibilities include, but are not limited to:Support regulatory compliance activities, including entering product specific attributes asprovided by program team representative into Regulatory Information Management System(RIM) (e.g. DRAGON). Provide support as needed for routine Health Authority (HA)...
-
Regulatory Reporting Assurance
2 weeks ago
Hyderabad, Telangana, India State Street Full timeBasic Purpose of Job:The Regulatory Reporting Assurance (RRA) department is a management assurance team in the Controller's Organization within Corporate Finance. The Regulatory Assurance team is responsible for the independent verification of controls and processes over global regulatory reporting, including Basel, Comprehensive Capital Analysis and Review...
