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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated organizational leadership skills at both functional and enterprise levels.
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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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Our work depends on Regulatory Affairs Manager joining our team to contribute to PKI and Identity Management policy development, technical liaison and advisor. Seize your opportunity to make a personal impact as a Regulatory Affairs Manager supporting a PKI Government High Value Asset Mission Essential Function program.
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This fellowship is intended to provide experience for Doctors of Pharmacy within the pharmaceutical industry with a focus on Regulatory Affairs for prescription drugs and devices at Novo Nordisk Inc. The fellow will gain the skills needed to pursue a career within the pharmaceutical industry where their education and experience can make a significant contribution to satisfying business needs and achieving company goals.
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Work closely with Global Patient Safety and Risk Management (GPSRM), Clinical Research, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs to inform clinical development and real-world outcomes and answer product- and disease-area research questions for Alnylam RNAi therapeutics using observational studies, EMR/claims data, and RWE. The Senior Director, Epidemiology reports directly to the Senior Vice President, Data Science, Statistics, and Epidemiology.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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Advanced life science degree or certification in Regulatory Affairs Sciences preferred. Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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The Vice President of Government Affairs will lead Veralto's government affairs strategy and operations globally, with overall responsibility for managing legislative, regulatory, political, and reputational risks while promoting growth opportunities.
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A minimum of 6- 10 years’ experience in product stewardship, regulatory affairs, compliance, chemical consultancy, and/or risk assessment. The ideal candidate will have experience in chemical and environmental regulatory compliance, packaging regulatio ns, product stewardship and industrial risk management in the medical device or manufacturing industries.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Initiates process improvements and contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams.
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Knowledge of HUD programs, regulatory compliance, the affordable housing industry, the Austin/Travis County Homelessness Response System, and the Homeless Management Information System (HMIS). The qualified candidate will coordinate service through the Veterans Affairs Supportive Housing (HUD-VASH) program and other rental assistance programs.
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Terminal degree in student affairs administration, educational policy, law or related field and eight years of experience in student conduct or higher education administration, academic discipline, residence life conduct management or other community agency relating to student development.
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Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards. Deep understanding of CDISC standards and regulatory submission requirements.
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Washington DC, Department of Consumer and Regulatory Affairs, Board of Industrial Trades, Class 1 – Steam Engineer License MD, Class 1 – Steam Engineer License. Ten (10) years’ experience as a mechanical engineer or journeyman mechanic with field experience in either maritime or industrial plant (construction, operation, or maintenance) as well as one of the following licenses: National Institute for the Uniform Licensing of Power Engineers, Inc. (NIULPE) First Class Power Engineer License.
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regulatory affairs jobs Title: intern Company: Medxcel
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