- Novo Nordisk Inc. (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
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways.… more
- 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
- Randstad US (Chicago, IL)
- regulatory affairs manager ii. + chicago , illinois (remote) + posted october 27, 2024 **job details** summary + $70 - $77.63 per hour + contract + no ... Eurpoe. Experience overseeing publishing vendors preferred. skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs … 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
- Takeda Pharmaceuticals (Montgomery, AL)
- … 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
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as a Sr associate, Global Regulatory Affairs CMC Submission Management where you will ... manage multiple and simultaneous projects. As part of the Regulatory Affairs CMC team, you will report...Collaborating with cross-functional teams to develop project plans for global regulatory submissions (IND/ IMPD/ CTA/ MAA)… 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
