Ra Cmc Submission Coordinator
2 days ago
Summary Provide regulatory CMC operational submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle Major accountabilities Perform compliance and operational activities including QC check DA checks and IND annual report writing CMC contact for some countries and compliance regulatory database entry and reports Create CMC submission documentation such as folders structure metadata forms RA request forms and act as data stewards in the applicable Regulatory Information Management System Ensure CMC documentation is eCTD compliant eCTD filenames assigned Document formatting DA checked PDF properties are compliant for eCTD submission documentation is finalized and eCTD file names assigned Coordinate data KPIs required for reports within RA CMC Support project teams for document finalization collate ancillary documents requirements from various sources e g databases OneNote trending etc and support coordination and management through the appropriate system Coordinate prepare and track CMC submissions for delivery to RA Operations Perform super-user role of RA CMC documentation system support super-user for e g account requests modifications as assigned Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System Support other GSOC team members for end-to-end submission coordination Key performance indicators High quality regulatory submissions and operational documentation Timeliness of deliverables No delays in approvals of clinical studies global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within RA CMC control Timely and accurate information communication about operational and compliance issues within own department and to key stakeholders Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines Regulatory compliance met in all compliance systems Build and maintain collaborative partnerships with stakeholder Partner with other GSOC team members to ensure business continuity xe2x80x8b Minimum Requirements Work Experience If University entrance or completed vocational training Preferably 2 years in regulatory and or experience in the pharmaceutical industry If Science Degree Preferably 1 year in regulatory and or experience in the pharmaceutical industry Working experience in pharma industry data systems and data management Ability to work successfully with global project teams and prioritize activities considering timelines and workload Effective planning organizational and interpersonal skills Prior publishing experience desired Computer literacy IT systems literacy Excellent data processing skills Skills Being Resilient Digital Technology Savvy Continuous Learning Interpersonal Savvy Operational Excellence Project Excellence Education Minimum General qualification for university entrance or completed vocational training Desirable Science Degree e g Chemistry Pharmacy Biochemistry Biotechnology Biology or equivalent Languages Fluent English required oral and written Good written spoken communication skills Skills Desired Analytical Skill Clinical Trials Collaboration Detail-Oriented Lifesciences Project Planning Regulatory Compliance
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RA CMC Senior Manager
15 hours ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearBandLevel 4Job Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Senior Manager
12 hours ago
Hyderabad (Office), India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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Ra Cmc Manager
3 weeks ago
Hyderabad, Telangana, India Novartis Full timeSummary Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities In addition interact with HA s on REG CMC questions to support new product or post marketed launches Key responsibilities Formulate and lead...
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Ra Cmc Associate Manager I
3 weeks ago
Hyderabad, Telangana, India Novartis Full timeSummary -Responsible for regulatory activities specifically related to chemistry manufacturing and control CMC Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities In addition interact with HA s on REG CMC questions to support new product or post marketed launches Major accountabilities Author high...
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Regulatory Affairs Manager
3 weeks ago
Hyderabad, India Amgen Full timeJob Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the...
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RA CMC Associate Manager I
5 days ago
Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob Description Summary-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.Job...
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RA CMC Associate Manager I
3 days ago
Hyderabad, Telangana, India Novartis Full time ₹ 12,00,000 - ₹ 24,00,000 per yearSummaryResponsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.About the RoleMajor...
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Specialist, Cmc Submission Management
3 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 lives of...
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Senior Specialist, Cmc Submission Management
3 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 lives of...
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Specialist, CMC Submission Management
2 weeks 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 the...
