Regulatory Affair Lead jobs
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REGULATORY AFFAIRS SPECIALIST I
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...
| Company | Fresenius Kabi Ag |
|---|---|
| Address | Lake Zurich, IL |
| Category | Information Technology |
| Job type | Full-Time |
| Date Posted | 3 weeks ago See detail |
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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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...
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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...
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- View all Biospace jobs - jobs in Lexington, MA
Compliance and Regulatory Lead
Kohler
New York, NY
Secure US and select international regulatory authorization for health/wellness products Oversee maintenance of regulatory licenses, registrations and listings Work with commercial team to ensure advertising and promotions comply...
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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 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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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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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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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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VP, Legal - Regulatory Affairs
A Biotechnology Company
Washington, DC
Working directly with clients, provide strategic and practical legal counsel on a wide variety of drug and medical device development legal and regulatory issues. As a strategic partner, work to identify and advise on business and...
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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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2024 Summer Intern -Regulatory Affairs
Colgate-Palmolive
Topeka, KS
Must be current student, in good academic standing, post-second year or higher, and seeking a degree in Grain or Feed Science, Animal or Veterinary Science, Animal Nutrition, Biology, or Business Analytics/ Information Systems. M...
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Associate Director, Congress Strategy Lead, Global Medical Affairs Oncology
Biospace
Boston, MA
Co-develop Oncology external engagement strategy and lead the development of the cross-portfolio Congress Strategy and narrative for global congresses.. Liaise cross-functionally within Global Medical Affairs Oncology, and with OT...
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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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Sr. Regulatory Affairs Specialist - Cardiac Diagnostics CDx
Boston Scientific
Hills, MN
Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices. Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, inc...
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Regulatory Affairs Senior Program Manager
Biospace
San Francisco, CA
6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...
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Manager, Regulatory Affairs CMC
Pix11
New York, NY
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...
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Manager, Regulatory Affairs CMC - Now Hiring
Takeda Pharmaceutical
Bronx, NY
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...
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Manager, Regulatory Affairs CMC
Biospace
Boston, MA
I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...
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Director, Regulatory Affairs
Biospace
San Diego, CA
Accountable for the development and implementation of the regulatory strategy for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively neg...
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Sr. Manager of Regulatory Affairs/ In-House Counsel at Software Company
Alchemy Legal
Los Angeles, CA
Lead and manage collections efforts, including developing strategies, negotiating settlements, and overseeing litigation processes. Handle litigation matters, including case management, legal research, and representation in legal...
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Regulatory Affairs Analyst
Brycetech
Washington, DC
CBRN Research and Analysis. CBRN Policy and Doctrine Support. Special Projects. Policy support to the Federal Radiological Preparedness Coordinating Committee (FRPCC). Planning support to the Chemical, Biological, Radiological/Nuc...
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Sr. Project-Program Manager, Regulatory Affairs
Arthrex
Naples, FL
Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs.. Develops project objectives by reviewing project proposals and business plans, conferring with senior management and key stakeholde...
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SVP, Global Regulatory Affairs
Biospace
Waltham, MA
Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...
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Associate Director, Regulatory Affairs
Biospace
San Rafael, CA
Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Cli...
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