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SPECIALIST - REGULATORY AFFAIRS
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
| Company | Biospace |
|---|---|
| Address | Plainsboro, NJ |
| Category | Information Technology |
| Job type | Full time |
| Date Posted | 2 weeks ago See detail |
Specialist - Regulatory Affairs
Biospace
Plainsboro, NJ
Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...
2 weeks ago seen See more...
- View all Biospace jobs - jobs in Plainsboro, NJ
Director Regulatory Affairs *Remote*
Providence
Beaverton, OR
Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...
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Manager, Regulatory Affairs
Invenergy
Chicago, IL
Monitor, coordinate and lead advocacy efforts at state economic and environmental regulatory bodies (public utility commissions, public service commissions, utility boards, state procurement entities, state EPA or siting authoriti...
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Director, Regulatory Affairs Strategy, Hematology
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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Director, Regulatory Affairs Strategy, Hematology
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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Senior Editor and Public Affairs Specialist (Senior Marketing Specialist)
University Of Maryland Baltimore
Baltimore, MD
Reg or CII Exempt StaffQualificationsReg or CII Exempt StaffJob: Reg or CII Exempt StaffShift: Day JobOrganization: School of Medicine - Public Relations and Public AffairsJob Posting: May 8, 2024Unposting Date: Jun 7, 2024, 10:59...
6 days ago seen See more...
Global Corporate Affairs, Senior Financial Analyst
Johnson & Johnson
New Brunswick, NJ
Prepare visual presentations of financial concepts for senior management. This includes developing complex financial graphs and charts. Examine existing financial concepts to identify areas for operational improvement, including...
7 days ago seen See more...
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Medical Affairs Operations Senior Manager-Americas (Hybrid)
Csl
Summit, NJ
Provide Medical Affairs (MA) project support regionally and engage team members to solicit project concerns and ideas for improvement. . Meet with MA Regional Head and Country Medical Leads to provide MA project status updates and...
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Senior Manager, US Medical Advertising and Promotions Regulatory (GI)
Biospace
Lexington, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.About the role:Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review, GI where you will be an interna...
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Head/ Sr Director of Global Regulatory Affairs
Predicine, Inc
Hayward, CA
Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...
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Director Regulatory Affairs
Nikang Therapeutics Inc
Wilmington, DE
Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...
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Manager - Regulatory Affairs - Therapeutic Area
Biospace
Plainsboro, NJ
Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...
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Senior Regulatory Operations Specialist – Digital Health Technologies (on-site)
Abbott
Alameda, CA
Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO. An excellent retirement savings plan with high employer co...
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Vice President Regulatory Affairs, Obesity
Biospace
Thousand Oaks, CA
Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process. Represents the Regulatory Affairs Therapeutic A...
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Senior Regulatory Counsel
A Digital Healthcare Company
San Francisco, CA
Provide legal guidance and counseling to business and functional teams (such as sales and marketing, regulatory affairs, medical affairs, government affairs, patient access, clinical, quality, R&D, finance, and others). Proactivel...
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Regulatory Affairs Specialist I
Fresenius Kabi Ag
Lake Zurich, IL
Collaborate with local and international colleagues to generate high quality submissions to obtain drug and/or medical device approvals in target markets. Gather design and development information on products from cross-functional...
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Regulatory Affairs Specialist
Argen Corporation
San Diego, CA
Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. Our Awesome Benefits!Working for a growing innovative compa...
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Senior Consultant - Operations and Regulatory Control
Northern Trust
Chicago, IL
Unspecified
Maintains established operational control processes of the operating group in accordance with the highest standards and best practices. Monitors and ensures regulatory changes are identified and implemented. Works with both direct...
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Senior Director, Global Regulatory Intelligence & Policy
Biospace
Basking Ridge, NJ
Leads day-to-day a team of Regulatory Intelligence Policy professionals across all major regions, incl. mentorship, performance mgmt., etc. Supports the team in both Regulatory Intelligence (collection, interpretation and communic...
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Senior Director, Regulatory Information Management
Biospace
Waltham, MA
Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...
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Manager Global CMC Regulatory Affairs
Johnson & Johnson
Titusville, NJ
Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...
2 weeks ago seen See more...
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Manager - Regulatory Affairs
Biospace
Lexington, MA
Compile, submit and maintain applications (IND, CTAs, NDAs etc.) to regulatory agencies in support of investigational and marketed products, including compiling and submitting responses to agency queries. Create and maintain produ...
2 weeks ago seen See more...
- View all Biospace jobs - jobs in Lexington, MA
Banking Regulatory Affairs, Assistant Vice President
Pix11
New York, NY
Background in regulatory relations and knowledge of heightened regulatory environment. Manage the standing MIS regulatory request process and submit all requested MIS to regulators. Provide support to RAO Team Leaders on regulator...
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Senior Attorney - State Regulatory (Las Vegas or Reno)
Nv Energy
Las Vegas, NV
Research and analysis techniques and application of federal, state, and local government laws and regulations. Analytical, interpersonal and communication (verbal and written) Assessing implications of proposed actions/arguments a...
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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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Director, Precision Medicine and Digital Health - Global Regulatory Affairs
Takeda Pharmaceuticals
Boise, ID
You will also establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests, and Digital tools to ensure goals/objectives are met. + Und...
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Director, Regulatory Affairs - Pharmaceuticals
Stryker
Mahwah, NJ
Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...
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Director, Digital Health Regulatory Affairs
Mcra
West Virginia, United States
Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...
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Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance
Ferring Pharmaceuticals
Parsippany, NJ
Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...
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