Associate Submission Manager
3 days ago
Provide operational support to the BR Submission manager with many of the tasks involved with the smooth running of regulatory submission preparation in compliance with Novartis processes. Collaborate with the SM in taking action to address issues as they arise. Ensure all assigned submission related activities are completed in compliance with in-ternal departmental process, SOP, and health authority guidance.
· May distribute workload to external vendor. Regularly maintain supporting IT systems/trackers to ensure accuracy of information by liaising with stakeholders. Provide operational support for selected CS&I and/or TM departmental compliance and submission activities, including deliverable tracking, issue reporting and escalation; ensuring stakeholders are held accountable for agreed actions and deliverables.
· May coordinate activities associated with the preparation of Clinical Trial Application submissions following internal working practice, guidance, and SOPs to ensure the delivery of high-quality submission documents to regulatory operations.
This includes creation of requisite templates, drafting of timelines, ensuring documents are finalized according to internal process via source data verification and formatting checks in accordance with agreed timelines.
· Manage the preparation activities associated with the IB compilation of TM-DP led IB annual updates in compliance with internal SOP and health authority requirements. Organizing and chairing the kick-off meeting to establish the level of update and contributors across Biomedical Research Translational Medicine and Development.
· Leads subsequent IB planning discussions, creating, and maintaining a comprehensive project plan capturing actions and key activities, target governance board review, content delivery timelines, and finalization date for IB. Manage stakeholder engagement, and ensure that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly and remediated.
· Timely escalation (as per agreed process) if the IB will not be finalized within the annual update period. Collaboration with Document Quality Management team to ensure strategic resource planning of downstream activities allowing IB to be finalized in accordance with targeted timelines.
Completion of all internal documentation and distribution of the final IB package in accordance with SOP and internal guidance. Timely update of all internal tracking systems.
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Associate Submission Manager
6 months ago
hyderabad, India Novartis Full timeYour responsibilities include, but are not limited to:Provide operational support to the BR Submission manager with many of the tasks involved with the smooth running of regulatory submission preparation in compliance with Novartis processes. Collaborate with the SM in taking action to address issues as they arise. Ensure all assigned submission related...
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Submission Manager
4 months ago
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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Submission Manager
4 months ago
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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Submission Manager
3 days ago
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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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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Submission Senior Specialist
4 months ago
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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Submission Senior Specialist
4 months ago
Hyderabad, India Bristol Myers Squibb Full timeDescription data in Workday, appropriate source per department or a contractor agreement. • Typically 5-9 bullet points; each describing a distinct and primary responsibility of the role. • Avoid generic comments such as “works well with others”, etc. • Tracks, collects, and reviews all components for submission to Health Authorities. •...
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Associate - RA Publishing
2 days ago
Hyderabad, India Makro Full timePosition: Associate RA PublishingLocation: Hyderabad Madhapur Telangana 500081Experience Required: 13 YearsEducation: Bachelor s Degree in Life Sciences or related fieldMarkets: US/UK/EU/ROWJob Summary:We are seeking a detailoriented and proactive Associate Regulatory Affairs (RA) Publishing with 13 years of experience in regulatory submissions across...
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Associate - RA Publishing
1 month ago
Hyderabad, India Makro Full timePosition:Associate RAPublishingLocation:Hyderabad Madhapur Telangana500081ExperienceRequired: 13YearsEducation:Bachelor s Degree in Life Sciences or relatedfieldMarkets:US/UK/EU/ROWJobSummary:We are seeking adetailoriented and proactive Associate Regulatory Affairs (RA)Publishing with 13 years of experiencein regulatory submissions across global markets...
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Regulatory Affairs Associate
4 months ago
Hyderabad, India Parexel Full timeHyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...
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Regulatory Associate
3 months ago
Hyderabad, India Makro Full timePositionTitle: Regulatory Associate(publishing)ReportsTo: Regulatory AffairsManagerPositionSummary: We are seeking a highly motivated andexperienced Regulatory Associate to join our Regulatory Affairsteam. The ideal candidate will have 24 years of publishingexperience within the Biotech/Pharma/CRO industry. This rolerequires strong knowledge of Chemistry...
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Associate Director, Global Regulatory Sciences-CMC
4 months ago
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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Associate Director, Global Regulatory Sciences-CMC
4 months ago
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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Associate Director, Global Regulatory Sciences-CMC
4 months ago
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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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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Regulatory Affairs Manager
3 months ago
Hyderabad, India SteriMax Inc. Full timeAbout UsSteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Responsibilities· Manages and provides leadership to an efficient and...
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Regulatory Affairs Manager
3 months ago
Hyderabad, India SteriMax Inc. Full timeAbout UsSteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Responsibilities· Manages and provides leadership to an efficient and...
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Senior Regulatory Affairs Associate-Biologics
3 months ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Senior Regulatory Affairs Associate Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets. Good understanding of regulatory framework, including regional trends,...
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Hub Associate
5 months ago
Hyderabad, India Blowhorn Full time**Hub Associate - Integrated Fulfillment**: **Operations** - Safety, Security, Inventory & Operations management of the warehouse is your responsibility. - Ensure timely planning and scheduling of vehicles to meet order delivery deadlines. - Ensure order management is done solely via in-house tech for all customer orders. - Ensure records of inventory...
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Bench Sales Recruiter
3 weeks ago
Hyderabad, India Boston Associate Software Systems Full timeCompany DescriptionBoston Associate Software Systems is an IT staffing and solutions firm based in Hyderabad. Established in 2016 as Boston Associate Technology Solutions, our company rebranded in 2018 to specialize in software development, staffing, and consulting services. We prioritize building relationships with both clients and consultants to provide...
