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SENIOR ASSOCIATE - REGULATORY AFFAIRS
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
| Company | Biospace |
|---|---|
| Address | Princeton, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 3 days ago See detail |
Senior Associate - Regulatory Affairs
Biospace
Princeton, NJ
Contribute to the preparation, review, approval, and dispatch of global submissions to regulatory applications (pre-submission activities, orphan drug applications, IND/INDs/CTAs/NDAs/MAAs etc.). Support the planning and conduct o...
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- View all - jobs in Princeton, NJ
Senior Specialist Regulatory Affairs - Nutrition - Lake County , IL or Columbus, OH New
Abbott Laboratories
Lake Forest, IL
$72,700 - $145,300 a year
Training and career development, with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives, and retirement plans Health care and well-being programs including...
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Senior Associate Regulatory Affairs
Amgen
Washington, DC
Execute the international regulatory strategy and regulatory plans.. Prepare supportive documentation for regulatory deliverables.. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).. Suppo...
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Senior Associate Regulatory Affairs
Biospace
Washington, DC
Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...
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- View all Biospace jobs - jobs in Washington, DC
Senior Manager/Associate Director of Regulatory Affairs
Tempus
Chicago, IL
Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...
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Senior Associate of Regulatory Affairs, CMC
Meitheal Pharmaceuticals Inc
Chicago, IL
Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...
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Regulatory Affairs Associate III
Teva Pharmaceuticals
Lorida, FL
Who we areTogether, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Write, review and compile documentation and data necessary for submission of assig...
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Regulatory Affairs Associate - North Chicago, United States - Validation Associates
Validation Associates
United States
As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership...
4 days ago seen
Senior Manager, Regulatory Affairs Vendor Governance
Biospace
California, United States
Own initiatives and day to day responsibilities in support of vendor oversight within RA. Negotiation and problem solving between Gilead RA leads and Vendor resources. Able to gather information or assign tasks or activities for o...
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- View all Biospace jobs - jobs in California State
Associate Manager, Regulatory Affairs (Hybrid)
Iff Family Of Companies
Hazlet, NJ
Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...
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Financial Regulatory Senior Associate or Counse...
A Global Law Firm
Washington, DC
Creative, innovative, resourceful and motivated. A team player. Welcoming of accountability and responsibility. An excellent writer and oral communicator. Capable of interacting with clients and preparing client-ready work product...
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Associate Director, Regulatory Affairs - Remote OR West Chester, PA
Teva Pharmaceuticals
West Chester, PA
Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Advertising and Promotion
Biospace
California, United States
Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...
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- View all Biospace jobs - jobs in California State
Associate Director, Regulatory Affairs - Inflammation & Immunology
Biospace
Basking Ridge, NJ
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Associate Director, Regulatory Affairs Strategy - Genetic Medicine
Biospace
New York, NY
Provide interpretation of regulatory authorities feedback, policies and guidelines.. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...
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Senior Associate, Regulatory Oversight Management
Bny Mellon
Pittsburgh, PA
Communicates with internal and external parties as needed and makes recommendations on necessary procedural/control changes on Regulatory Oversight Management matters. Gathers data and prepares materials for more senior team membe...
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Associate Director - Regulatory Affairs - AD Promo
Biospace
Princeton, NJ
Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...
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Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc.
Johnson & Johnson
Santa Clara, CA
...
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Counsel Senior Manager - Legal Entity Governance: Public, Regulatory and Corporate Affairs
Wells Fargo
Charlotte, NC
Work on matters for the subsidiaries of Wells Fargo & Company, including support for all aspects of Legal Entity corporate governance, planning and preparing for board and committee meetings, overseeing board evaluations for subsi...
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- View all Wells Fargo jobs - jobs in Charlotte, NC
Senior Manager, Regulatory Affairs - Proliant Health & Biologicals
Lauridsen Group, Inc.
Ankeny, IA
Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...
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- View all Lauridsen Group, Inc. jobs - jobs in Ankeny, IA
Regulatory Affairs Associate - Drug Products (Princeton, NJ (USA), US)
Laboratoire Guerbet
Princeton, NJ
Participate in pre-submission meetings with FDA in order to agree on potential regulatory pathways, clarification and follow-up of submissions under review. Coordinate preparation, review, submission of e-CTD regulatory dossiers t...
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Senior Manager Regional Regulatory Affairs
Biospace
King Of Prussia, PA
You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...
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Senior Regulatory Affairs Specialist
Iconma, Llc
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
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Senior Regulatory Affairs Specialist
Axelon
Saint Paul, MN
This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...
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Senior Regulatory Affairs Specialist
Collabera
Saint Paul, MN
Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...
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VP/Senior VP, Regulatory Affairs
Biospace
San Diego, CA
Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...
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