- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the ... global regulatory aspects of Eisai's products under development and post...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Merck & Co. (Rahway, NJ)
- …IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, ... with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices...People Leadership, Product Lifecycle, Regulatory Affairs Compliance, Regulatory Affairs … more
- Pall (Port Washington, NY)
- …and innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets ... turn ideas into impact - innovating at the speed of life.As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on… more
- Merck & Co. (Rahway, NJ)
- …Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... Job DescriptionThe Director / Principal Scientist, Regulatory Affairs...Compliance Programs, Cross-Functional Teamwork, Drug Development, Economic Impact Analysis, Global Regulatory , Regulatory Affairs… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- …SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global Trade Services, ... Development Division scientists, our Manufacturing Division and Animal Health product experts, global regulatory , controlled substances and others to enable the… more
- Merck & Co. (Rahway, NJ)
- …Systems (PMIS), Project Risk Assessments, Regulatory Affairs Management, Regulatory Reporting, Regulatory Training, SAP Global Trade Services, Social ... Reporting to the Customs & International Trade (CIT) Valuation Associate Director , the Senior Specialist position's core responsibilities are to oversee our… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and execute Oncology ... regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise...Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- Danaher Corporation (Port Washington, NY)
- …Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. Director Global Quality and Regulatory ... ideas into impact - innovating at the speed of life. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Global … more
- Merck (Rahway, NJ)
- …No **Hazardous Material(s):** n/a **Required Skills:** Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, People Leadership, ... with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices...Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... will be based on qualifications listed below. Purpose: The Director provides specialist medical and scientific strategic and operational...area required. + 7-10 years of experience in Medical Affairs with Global Medical Affairs … more
- AbbVie (Florham Park, NJ)
- … Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory , HEOR and other functional areas, provides leadership, oversight, and support ... title will be based on qualifications listed below. Purpose: The Senior Director provides specialist medical and scientific strategic and operational input into core… more
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (50% hybrid) Type: 12-month contract Must haves: + Must be local for hybrid ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help… more
- Merck (Rahway, NJ)
- …Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** The Director /Principal Scientist, Regulatory Affairs ...Compliance Programs, Cross-Functional Teamwork, Drug Development, Economic Impact Analysis, Global Regulatory , Regulatory Affairs… more
- Bristol Myers Squibb (Madison, NJ)
- …Management, site and above site QA and QC, Internal and External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Global Product Quality (CTGPQ) is… more
