- Merck & Co. (Rahway, NJ)
- …Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions , Strategic Thinking {+ ... WORK WITHIN A COMMUTABLE DISTANCE AND BE ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the… more
- Insmed Incorporated (NJ)
- … to regulatory agencies.What You'll Do: Prepare, compile, and publish regulatory submissions (INDs, NDAs, annual reports, supplements, amendments) in eCTD ... format using industry-standard publishing tools.Manage regulatory submission content and metadata within Veeva Submissions Vault, ensuring compliance with… more
- Insmed Incorporated (NJ)
- … contact for the US FDA. The GRL will be accountable for regulatory submissions , communications, and negotiations with global Health Authorities for designated ... global CTA submission strategiesDirect the planning and coordination of global regulatory submissions , including clinical trial applications for multinational… more
- Eisai, Inc (Nutley, NJ)
- …as Latin America, the Middle East, and Africa.The Director will manage regulatory submissions , registrations, and lifecycle management activities for new and ... broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration strategy/ submissions .… more
- GRAIL (Atlanta, GA)
- …degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions ...with regulatory strategy and the development of submissions in partnership with key internal and external stakeholders… more
- Terumo Neuro (Aliso Viejo, CA)
- …that span outside of immediate job area. + Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the ... regulatory agencies through oral and written communications regarding pre- submissions strategies, potential regulatory pathways, compliance test requirements,… more
- HSBC (Buffalo, NY)
- …and other BAU activities. They are responsible for reviewing and approving regulatory submissions including ad hoc requests, responses to examinations, and ... wider technology teams, RLO, 3LOD, 2LOD and CCO to ensure regulatory submissions are accurate and consistent across technology, controls are assessed… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participate in teams for sustaining products to provide input on global regulatory requirements. + Support regulatory submissions , filings, and responses ... and software as a medical device (SaMD), preferred. + Knowledge of regulatory submissions such as 510(k), De Novo, or CE marking for software-based medical… more
- Olympus Corporation of the Americas (Westborough, MA)
- … due diligence in vendor and technology selection. + Oversee and support regulatory submissions and compliance filings where applicable (eg, AI risk ... practices is desirable. + Experience with 510(k), De Novo submissions , CE marking, and international regulatory pathways...De Novo submissions , CE marking, and international regulatory pathways for Software as a Medical Device highly… more
- Eisai, Inc (Philadelphia, PA)
- …and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. ... provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Cybersecurity regulations, and relevant consumer protection laws). + Oversee and support regulatory submissions and compliance filings where applicable (eg, AI ... This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU). The DU is a high-growth,… more
- Parexel (Juneau, AK)
- …Excellence - Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions - Develop CMC strategies for products across all ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- CSL Behring (King Of Prussia, PA)
- …years' experience in the biotech or pharmaceutical industry, with exposure to regulatory activities/ submissions and 3 years working on developmental products. ... therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to… more
- BeOne Medicines (San Mateo, CA)
- … submissions + Oversee and be accountable for Dx/CDx and Device related regulatory agency communications, submissions , and approvals, with a quality focus to ... **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be...for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for… more
- CSL Behring (King Of Prussia, PA)
- …program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within ... to study design and data analysis for clinical trials and regulatory submissions + Influence and contribute to clinical development plans, collaborate with… more
- ITG Brands (Greensboro, NC)
- …WILL DO Lead the development of toxicology strategies for PMTA and other regulatory submissions , ensuring alignment with FDA expectations and public health ... compliance and consumer safety. Author and manage the toxicology sections of regulatory submissions , ensuring scientific rigor, clarity, and completeness Direct… more
- ITG Brands (Greensboro, NC)
- …executing, and interpreting behavioral and human factors research to support regulatory submissions , including PMTAs. This role focuses on understanding ... data interpretation. Strong scientific writing and presentation skills for regulatory submissions and external engagement. Effective project management… more
- Formation Bio (New York, NY)
- …in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions : Author, and contribute to regulatory ... submissions , including INDs, BLAs, and other regulatory dossiers. Due-Diligence Support: As part of Formation Bio's strategy to in-license programs and develop to… more
- Insmed Incorporated (NJ)
- …commercial objectives. You will author, review, and approve CMC sections of regulatory submissions including INDs, NDAs/MAAs, and other required documentation. ... small molecule process chemistry, formulation, and analytical development.Demonstrated success in regulatory submissions and global CMC regulatory … more
- Merck & Co. (Rahway, NJ)
- …complex scientific information to a range of audiences.Experience with regulatory submissions and compliance related to biophysical characterization.Demonstrated ... Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Submissions {+ 5 more}Preferred… more
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