Search Results: 7,022 vacancies
...ObjectiveLead and or/support the creation and approval of global regulatory plans in conjunction with Regulatory LeadsPosition... ...documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters...
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About the OpportunityOur client is a growing biopharmaceutical company in need of a Sr. Manager/Associate Director of Regulatory Affairs Strategy to join their team. This role is responsible for developing, implementing, and leading short/long term global regulatory strategies...
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...passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role... ...our hybrid policy. This position will report to the Regulatory Strategy Team Lead.... ...regulatory strategies throughout life-cycle management are in place and implemented including...
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...SUMMARY OF POSITION Manages team and leads Regulatory Associates and/or Senior Regulatory Associates in regulatory activities associated with planning... ...will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files. Ensures that all due dates...
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...LinkedIn.
Job Description
Purpose
The Reporting Specialist I is responsible for... ...submissions
Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA... ...and where they are in the process
Manages regular reporting needs and external...
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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid... ...dossiers, change controls and technical reports. He/she coordinates directly with key stakeholders... ...for meetings).
He/she defines and manages the compilation of the documentation, required...
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...Johnson & Johnson's Family of Companies, is recruiting for a Lead Regulatory Scientist. This position can be located in Spring House, PA;... ....Experience responding to Health Authority (HA) requests, managing HA interactions, and life cycle management applications is preferred...
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...based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.
The Manager of Regulatory Affairs (RA) Labeling will assist in the development of a cross-functional labeling strategy for products worldwide,...
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Local area
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Worldwide
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3 days per week
...essential to fulfilling our purpose.
The Role
The Director, Regulatory Advertising & Promotion is responsible for ensuring that all... ...and influence cross-functional teams.
Ability to manage multiple projects and prioritize competing deadlines.
Ability...
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...& Johnson's Family of Companies is recruiting for a Scientist, Regulatory CMC Dossier located in Spring House, PA; Malvern, PA; Horsham,... ...dossier updates and meet regulatory timelines· Prepare, review, manage, and lead responses to CMC related questions from regulatory authorities...
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...Regulatory Manager/Sr Manager
Princeton, NJ
Hybrid
In this role our ideal candidate will serve as a lead regulatory support for DSM Firmenich’s Taste Texture and Health (TTH) North America team flavor and ingredient technologies. Will deliver exceptional...
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Flexible hours
...equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal... ...Global Regulatory Affairs Compliance Manager for US/EU will play a pivotal role in... ...framework for the US and EU. This position reports to the VP, Quality and Regulatory...
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...Innovative Medicine, is recruiting for an Associate Director, Regulatory Process Development (RPD). The position can be located in Beerse... ....Support the generation and implementation of an E2E process management model across Global Regulatory Affairs (GRA), including...
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...Contributing to the formulation and execution of the regulatory strategy by assessing areas of supervisory focus, monitoring the regulatory... ...regulatory intelligence. Establishing and maintaining a proactive engagement and cov Regulatory, Director, Management, Insurance...
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Regulatory Specialist (East Windsor, NJ) (Multiple Openings). Review, manage and write regulatory submissions electronically which include New ANDA filings, Complete Response... ...); review of the leachable and extractable reports generated for the oral Liquid & Solution drug...
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...Description
Job Description SUMMARY OF POSITION
The Sr. Manager, Regulatory Affairs integrates and applies knowledge of US regulatory... ...preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence, as...
...working-with-us.Position Responsibilities The Associate Director, Regulatory Affairs will develop and implement global regulatory strategy... ...environment. Excellent organizational, communication and time management skills needed to manage multiple ongoing projects...
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...working-with-us.We are seeking a highly skilled and experienced US Regulatory Lead to join our dynamic regulatory affairs team. This pivotal... ...collaborate cross-functionally with internal teams to lead and manage all aspects of the BLA preparation, submission and reviewServe...
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...-with-us.ResponsibilitiesLeadership responsibility for global regulatory strategy within the Hematology portfolio. Responsible for understanding... ...teams and across functions. Experience applying project management techniques within teams. Experience in effectively managing...
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...Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one... ...make a difference?
The Position
Manage and oversee all assigned projects/products... ...personnel.
Relationships
Report to the Director/Associate Director/Lead...
Local area
Night shift
