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A leading manufacturer of institutional cleaning chemicals, equipment, and specialty coatings is seeking a Senior Regulatory Affairs Manager to oversee compliance across U.S. and international markets. Review and approve all product labels and materials for compliance with OSHA, EPA, FDA, DOT, FIFRA, CPSC, VOC, and other applicable standards. Maintain accurate and up-to-date SDS records, classification codes, and emergency protocols (e.g., Chemtrec). Manage compliance for REACH, CEPA, NAFTA classifications, DOT container testing, SCAQMD, mill assessments, and EPA registrations. Extensive experience in regulatory affairs, preferably in chemical or equipment manufacturing
Meet has partnered with an exciting, pre-IPO biotech that is developing treatments for hematological conditions utilizing an innovative cell therapy platform. You will lead the planning and development of key regulatory submissions (IND/CTA, BLA/MAA) with cross-functional team members. Experience leading programs from IND/CTA through BLA/MAA required.. Staffing and Recruiting, Pharmaceutical Manufacturing, and Biotechnology Research.. Head of Regulatory Affairs, Cell Therapy Immunology
At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Lead Correspondence with US Agencies (CVB-IC and FD-ORA).. Maintain current registrations with the US Drug Enforcement Administration.. Biological/Chemistry based degree: B.S. with 14 years, M.S. with 12 years, or DVM/Ph. D. with 9 years, with direct experience in biological or pharmaceutical science development or manufacture. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.. The Director of Regulatory Affairs Strategy is responsible for integrating and applying knowledge of global regulations governing radiopharmaceutical drug development for assigned programs to advance the development and commercialization of the Company's portfolio of assets.. Drive and manage the submission plans and authoring of content for assigned programs for IND/CTA/IMPD/NDA applications, including meeting requests, briefing documents, etc.. Reviews Technical Operations, and Development documentation intended to support IND/CTA/IMPD/NDA applications for regulatory compliance.. Serves as the primary contact for IND/CTA/IMPD/NDA filing materials and questions for assigned programs, ensuring they are completed in accordance with regulations.
Oversee and manages regulatory exams, inquiries and third-party reviews for Stone Group Inc. registered investment adviser and broker dealer affiliates. Handles regulatory examinations and other engagements administered by state and federal regulatory entities including SEC, FINRA, OCC, DTCC and State Securities Regulators. The successful candidate will possess seven or more years' experience at a broker-dealer, registered investment, regulator or law firm responding to inquiries and performing regulatory affairs functions. Communicate with business partners in Equity/Fixed Income Trading, Operations, Clearing, Finance, Risk and Legal throughout regulatory inquiry and exam process to manage expectations and outcomes. BA/BS or a similar degree required; MBA/JD preferred
Accreditation/Regulatory Affairs Manager. Join to apply for the Accreditation/Regulatory Affairs Manager role at MUSC Health. The Regulatory Affairs / Accreditation Manager (Charleston-Orangeburg/Nexton campus) reports to the Charleston Director for Regulatory Affairs/Accreditation.. CC002249 CHS - Regulatory/Accreditation. Get notified about new Regulatory Affairs Manager jobs in Charleston, SC
We provide power generation and storage solutions at scale around the world to create a cleaner energy future. Engage with the relevant state agencies and other stakeholders in conjunction with or at the direction of development and government affairs. Bachelor’s degree in Business, Economics, Finance, Law, Political Science, Environmental Policy, Engineering, or related field.. MBA, MA or law degree.. Knowledge of FERC and NERC standards related to transmission and interconnections, including Open Access Transmission Tariff (OATT) preferred.
Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents. Master Degree (MS/MA) Science degree (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required.. Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
A growing medical device company known for its Class III implantable technologies are seeking a Director of Regulatory Affairs to lead strategy and execution across the US. Lead a talented regulatory team in developing and executing submission strategies (PMA, IDE etc.. Experience with PMA/IDE submissions. Associate Director, Regulatory Affairs - Global Labeling Foster City, CA $165,495.00-$235,620.00 3 weeks ago. Associate Director of Regulatory Affairs Director, Global Quality & Regulatory Affairs We’re unlocking community knowledge in a new way.
Join to apply for the Sr. Regulatory Affairs Specialist role at Convatec. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.. Liaise with external consular services agents to coordinate and arrange notary, apostille and legalization as required.. Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles.. Senior Consultant - Regulatory Operations Software Implementation (Remote)
The Director, Regulatory Affairs is a senior leadership role responsible for overseeing all aspects of regulatory compliance, advocacy, and strategic engagement with regulatory bodies.. Ensure that nuclear facilities and operations are in full compliance with regulatory standards such as the Atomic Energy Act, the Code of Federal Regulations (CFR), and industry-specific safety and environmental standards.. Work closely with senior leadership to integrate regulatory considerations into long-term business strategy, including nuclear plant construction, upgrades, or decommissioning.. Bachelor's degree (minimum), Master's or advanced degree preferred (e.g., Nuclear Engineering, Regulatory Affairs, Environmental Science, Law).. 15+ years in nuclear power industry, with 10+ years in regulatory affairs, including leadership experience in managing teams and projects, and specific regulatory experience with NRC or equivalent bodies.
Reports To Vice President General Counsel and Corporate Secretary.. Engage, establish, and foster positive, impactful and trusted relationships with Canadian regulators, FERC staff and Commissioners, state Public Utility Commissions, legislative bodies, state or provincial energy offices, trade groups, professional associations, and industry professionals through outreach and education related to reliability and security of the BPS. Juris Doctorate from an ABA accredited institution and/or Bachelor of Science with emphasis in power systems from ABET-accredited engineering school is desired.
Clinical-Stage Biotech | Bay Area | Hybrid (2-days on-site). Proclinical is partnering with a rapidly growing clinical-stage company advancing a high-potential pipeline in the immunology space.. With multiple assets in mid-stage development, they're looking to bring on a Senior Regulatory Affairs Leader to drive global strategy across a dynamic portfolio.. 10+ years of Regulatory Affairs experience in development-stage biotech. Director Life Sciences Regulatory Affairs and LabelingSenior Manager/Associate Director Clinical Quality Assurance Auditor
Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise.. Postgraduate degrees relevant to the role ( e.g. MSc, PhD , PharmD, MD ) a plus. Experience working in regulatory documentation system (like Veeva). At AstraZeneca's Alexion division, we push boundaries in rare disease biopharma by translating complex biology into transformative medicines.. With our global reach and resources, we are shaping the future of rare disease treatment, helping people live their best lives.
A leading manufacturer of institutional cleaning chemicals, equipment, and specialty coatings is seeking a Regulatory Affairs Director to oversee compliance across U.S. and international markets. Review and approve all product labels and materials for compliance with OSHA, EPA, FDA, DOT, FIFRA, CPSC, VOC, and other applicable standards. Maintain accurate and up-to-date SDS records, classification codes, and emergency protocols (e.g., Chemtrec). Manage compliance for REACH, CEPA, NAFTA classifications, DOT container testing, SCAQMD, mill assessments, and EPA registrations. Extensive experience in regulatory affairs, preferably in chemical or equipment manufacturing
The Senior Regulatory Affairs Specialist (Advertising & Promotional Review) leads the end-to-end review process for promotional and non-promotional content across Stallergenes Greer portfolio of products.. Ensures all materials comply with Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and Office of Prescription Drug Promotion (OPDP), and other regulatory requirements while fostering a culture of collaboration and compliance.. Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off processes.. 3 - 5 years’ experience in biopharmaceutical and/or medical device Regulatory Affairs, with specifically 1+ year in advertising and promotional review.. Proven experience working with Veeva PromoMats and supporting submissions to CBER/OPDP.
Wixon, a respected and innovative flavor and spice manufacturer based in Southeast Wisconsin, is seeking a Director of Regulatory Affairs to lead our efforts in regulatory compliance, food safety, and product labeling.. Oversee compliance with Kosher, Halal, Organic, Non-GMO Project Verified, and Gluten-Free programs.. Represent Wixon in regulatory interactions with customers and government agencies; lead crisis management for product recalls or withdrawals.. Manage departmental budgeting, performance tracking, and technology systems including IFS, Optiva, Genesis (Trustwell), and more.. Our corporate campus in St. Francis, Wisconsin, visit our website for more company information at www.
Key Responsibilities: Lead global regulatory activities and strategy development for clinical regulatory filings.. Oversee the preparation, review, and submission of regulatory documents, including INDs and FDA submissions.. Guide project teams in interpreting and communicating regulatory requirements.. Education: BA/BS degree in biological or physical sciences preferred.. Proficient in MS Office and experience with document management systems.
Responsible for regulatory, franchising, and public policy matters for City of Chicago, Cook County, and Northwest Indiana.. Develops and implements legislative strategies, monitors legislation and coordinates state association management.. Develops and implements strategy for government affairs and public policy issues for specific franchises as well as strategy for local regulatory initiatives.. Government Affairs, Leadership, Local Government, People Management, Strategy Implementation, Taking Initiative Compensation. Most sales positions are eligible for a Commission under the terms of an applicable plan, while most non-sales positions are eligible for a Bonus.
Director, Government & Regulatory Affairs page is loaded Director, Government & Regulatory Affairs Apply locations IL - Chicago, 1255 W North Ave time type Full time posted on Posted 2 Days Ago time left to apply End Date: August 9, 2025 (6 days left to apply) job requisition id R417500 Comcast brings together the best in media and technology.. Responsible for regulatory, franchising, and public policy matters for City of Chicago, Cook County, and Northwest Indiana.. Develops and implements legislative strategies, monitors legislation and coordinates state association management.. Develops and implements strategy for government affairs and public policy issues for specific franchises as well as strategy for local regulatory initiatives.. Most sales positions are eligible for a Commission under the terms of an applicable plan, while most non-sales positions are eligible for a Bonus.