- Chiesi (Cary, NC)
- …requirements into practical application to ensure the success of pre-approval drug development programs. Supports regulatory agency interactions, communications, ... + General knowledge of the drug development process, of drug regulations, regulatory procedures and drug development guidance + Effective in verbal… more
- Takeda Pharmaceuticals (Boston, MA)
- …with line management + Supports and/ or leads assigned device and drug -device combination aspects of US regulatory submissions and internal documentation ... CMC and Medical Device experience, including experience as a regulatory representative for device and drug -device combination...as a regulatory representative for device and drug -device combination products in US + Experience working on… more
- Lilly (Indianapolis, IN)
- …content including gap analysis and recommendations, advise on expedited pathways, orphan drug designation, and other regulatory advice meetings, and provide ... college or university + At least 7 years of regulatory affairs experience with research-based drug development,...years of regulatory affairs experience with research-based drug development, including early phase (first in human, Ph1/Ph2)… more
- Amazon (Bellevue, WA)
- …external regulatory authorities. * Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company ... dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug .... Regulatory Affairs Certification (RAPS) - . Drug and Biologics regulatory filing experience Amazon… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of prescription drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple ... preferred. + You have a minimum of 4 years' experience in drug , biologic or device Regulatory Affairs or related field, including a minimum of 2 years'… more
- Lundbeck (Deerfield, IL)
- …for assigned products. + Acts as FDA contact for assigned products. Liaises with regulatory authorities for all drug development and approval aspects. + Manages ... biotech industry + 5+ years direct experience in US Regulatory Affairs + Direct experience in US drug... Regulatory Affairs + Direct experience in US drug development and regulatory submissions supporting investigational… more
- MyFlorida (Tallahassee, FL)
- …Date: 02/28/2025 Total Compensation Estimator Tool (https://compcalculator.myflorida.com/) DIVISION OF DRUG , DEVICES & COSMETICS Regulatory Specialist II ... REGULATORY SPECIALIST II - 79011477 Date: Nov 24,...Cosmetics (DDC) regulates under the provisions of the Florida Drug and Cosmetic Act (Chapter 499, FS) by licensing,… more
- MyFlorida (Tallahassee, FL)
- …Date: 04/21/2025 Total Compensation Estimator Tool (https://compcalculator.myflorida.com/) DIVISION OF DRUG , DEVICES & COSMETICS Regulatory Specialist I Position ... REGULATORY SPECIALIST I - 79011476 Date: Nov 19,...and Cosmetics (DDC) regulates under provisions of the Florida Drug and Cosmetic Act (Chapter 499, FS) by licensing,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …teams and mentoring colleagues. + Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, ... the USA or more jurisdictions. + Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market… more
- Haleon (Warren, NJ)
- …through professional organizations / associations. + Analyze changes to key Regulatory Authorities' policies relating to drug labelling and recommend/coordinate ... achieve our goals: + Bachelor's degree. + Pharmaceutical industry experience with drug development and regulatory requirements. + Line leadership experience. +… more
- Novo Nordisk (Lexington, MA)
- …advanced degree is strongly preferred + Minimum of 10 years drug development/FDA/ regulatory related industry experience required + Demonstrated knowledge ... regulatory agencies, including the FDA + Experience with rare disease drug development, innovative trial design and/or expedited regulatory pathways, highly… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet ... help create possible, together. **Job Description** **Senior Manager, Biostatistics - Clinical Drug Dev - Virology** United States - Foster City, CA or Parsippany,… more
- Bristol Myers Squibb (Princeton, NJ)
- …, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and ... integrate one global compliance program into the Worldwide Medical, R&D and Global Drug Development Organizations . In this role, you will combine your knowledge… more
- Pfizer (Cambridge, MA)
- …reviewing and managing analytical characterization sections for antibodies and antibody drug conjugates for regulatory filings; Performing and managing extended ... Pfizer Inc. is seeking a Antibody Drug Conjugate (ADC) Molecule Analytical Product Specialist in...Collaborate with internal teams in process development, manufacturing, quality, regulatory , supply chain, and with external CDMOs to advance… more
- AbbVie (North Chicago, IL)
- …expertise across CMC disciplines to further program goals via collaborations with drug product development, regulatory affairs, and commercial operations. + The ... Research Scientist II to conduct process research and development of antibody- drug conjugates from pre-clinical through clinical development. Job Description We are… more
- Amgen (Washington, DC)
- …on US regulatory mechanisms to optimize product development (eg orphan drug , fast track, early access, pediatric plan) + Exchange regulatory information ... Qualifications:** Doctorate degree and 2 years of experience in regulatory or pharmaceutical drug development Or Master's degree and 4 years of experience… more
- Takeda Pharmaceuticals (Lexington, MA)
- …FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory strategic oversight ... + You will have a minimum of 5 years' experience in drug , biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years' experience… more
- Lilly (Indianapolis, IN)
- …of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing and ... commercialization or manufacturing + Demonstrated deep knowledge of the biologic drug development process. + Bioproduct Regulatory CMC experience supporting… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …complex and proactive global monitoring and surveillance of changes in the regulatory landscape focused on drug development lifecycle starting from preclinical ... for the most current changes and information in the drug development space + Assess regulatory intelligence...in the drug development space + Assess regulatory intelligence information for relevance and impact to company's… more
- Englewood Lab, Inc (Totowa, NJ)
- … Regulatory Affairs for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc.), under the ... degree (Life Sciences, Engineering, related profession) + Experience of drug , cosmetic, medical device regulatory process is...+ Experience of drug , cosmetic, medical device regulatory process is a pre-requisite + Familiarity with FDA… more
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