- Fresenius Medical Center (Waltham, MA)
- …May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff. **EDUCATION:** Bachelor's Degree required; Advanced ... **PURPOSE AND SCOPE:** Oversees all regulatory activities for new and mature products to...applications, IND/ODA annual reports, amendments) in the electronic format ( eCTD and eFiling). + Develops, implements and maintains various… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …evidence, and creating hope for all facing illness. The Director, Regulatory Affairs (Early Development) provides strategic global regulatory guidance to ... and guidelines. + Leads as a key member of Global Regulatory Project Teams. + Leads multidisciplinary...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Abbott (South Portland, ME)
- …results for millions of people. **What You'll Work On** The **Sr. Specialist, Regulatory Affairs ** combines scientific, regulatory , and business knowledge to ... Abbott is a global healthcare leader that helps people live more...fields. + Minimum of 3 years of experience in regulatory affairs preferred; experience in quality assurance,… more
- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports to labeling ... rapport and working relationships with company stakeholders. Effective collaboration with Regulatory Affairs , CMR, Supply Chain, and HQ colleagues regarding… more
- Takeda Pharmaceuticals (Columbus, OH)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues...and process is required. + At least two major eCTD (original or supplement) registrations and several minor (amendment)… more
- System One (Florham Park, NJ)
- …with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, ... Teams if deemed appropriate by manager. + Maintain knowledge of local and global regulatory submission requirements. + Assist in supporting Regulatory … more
- Vera Therapeutics (Brisbane, CA)
- …scientifically accurate manner. * Work with functional representatives such as regulatory affairs , clinical and nonclinical development, clinical pharmacology, ... with overall regulatory and program timelines in coordination with regulatory affairs , project management, and cross-functional leadership. * Communicate… more
- Chiesi (Cary, NC)
- … Clinical Development Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US **_About ... Briefing Books, eCTD modules, represent clinical aspects during interaction with Regulatory Authorities * Regularly updates the CDP team all aspects discussed at… more
- Organon & Co. (Plymouth Meeting, PA)
- …in supporting ongoing clinical research and interface extensively with Clinical Development, Regulatory teams, and Medical Affairs , among other internal teams, ... responding regulatory questions. + Proven experience and expertise in eCTD submissions (eg, NDA/BLA/PMA). + Comprehensive understanding of regulatory … more
- RELX INC (Philadelphia, PA)
- …in building long-term relationships with high-level decision-makers, including procurement, regulatory affairs , and compliance departments. + Track Record: ... teams and senior leadership. + Industry Knowledge: Deep understanding of life sciences regulatory compliance, including UDI, eCTD , SPL, and GxP, with the ability… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines ... 2022. The company handles research, clinical development, sales, marketing, medical affairs , supply chain,and business development functions. MTPA is dedicated to… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …statistical programing support for early and late-phase clinical development and medical affairs studies including analyzing data. This position is for a flexible, ... specs, validates SDTM, ADaM datasets and TFLs Identifies problems and develops global tools that increase the efficiency and capacity. + Responsible for… more