- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi ... into a global strategy.Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...knowledge of regulations, such as ICH is desirable.Experience with CTD/ eCTD preparations preferred. Travel: Ability to travel up to… more
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary:** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director, Regulatory Affairs provides strategic global regulatory guidance ... 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 (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
- Vera Therapeutics (Brisbane, CA)
- …and review, eCTD Publishing, review and archiving consistent with global regulatory requirements for different application types. Responsibilities: * Assist ... Publishing will be a key contributor to Vera Therapeutics' Regulatory Operations and Regulatory Affairs ...of regulatory submission documents in compliance with global regulatory requirements for different application types… more
- Novo Nordisk (Lexington, MA)
- … submissions, which may include: + Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational ... About the Department Our East Coast Global Development Hub brings together the best minds...teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of… 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
- BeiGene (San Mateo, CA)
- …executive level meetings as required for communication and transparency. Interface with Regulatory project managers, Regulatory Affairs , and submission ... In this role, this person will serve as the Regulatory Operations representative on Global Submission filings...+ Successful candidates will have significant experience within a Regulatory Publishing environment including hands on eCTD … more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... Therapy Designation requests + Clinical summary and overview documents in eCTD format for global regulatory submissions + Shares knowledge and experience to… 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
- Chiesi (Cary, NC)
- … Clinical Development Job Type: Direct Employee Team: R&D, Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Cary, NC, US **_About ... special care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification** , a recognition of… 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
