Regulatory Affairs Jobs in Newark
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Search Results - Regulatory Affairs Jobs in Newark
Tehk Recruitment Ltd-Newark
Director, Regulatory Affairs (FDA)
New Jersey
• New role to the business
• Individual Contributor role and strategic also
• The only role of its type in the local site / location
• Responsible for EVERYTHING to do with Regulatory Affairs...
jobvertise.com -
Daiichi Sankyo, Inc.-Newark
between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist...
jobg8.com -
Newark
Jersey State Assembly and Senate.
• Tracks and reviews proposed legislation of importance to the Authority and contributes to bill comments prepared by the Legislative & Regulatory Affairs team on proposed legislation that directly or indirectly impacts...
icims.com -
Daiichi Sankyo, Inc.-Newark
pharmaceutical experience including 5 years of experience within Regulatory Affairs
• Knowledge of IND, NDA/BLA submission experience
• Experience with regulatory submission strategy globally will be preferred but not required.
• Experience in providing...
jobg8.com -
Newark
and Regulatory Affairs in the preparation of project-related documents and regulatory submissions, including Investigator’s Brochures, Annual Reports, INDs and NDAs.
• Participate in investigator meetings, capturing VOC and translating company needs/strategy...
pacira.com -
Daiichi Sankyo, Inc.-Newark
discipline required
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred
Experience Qualifications
• 4 or More Years in the pharmaceutical industry preferred
• 1 or More Years in regulatory affairs required
• Experience in (s)NDA/BLA filing...
jobg8.com -
Newark
Sales, Professional Education, Regulatory Affairs, and Legal; and with external consultants.
Qualifications:
Qualifications:
• Proven ability to think strategically and succeed with indirect influence and independent direction
• Current and relevant...
pacira.com -
Daiichi Sankyo, Inc.-Newark
Ph.D., MD, JD) preferred.
Experience Qualifications:
• 10 or More Years in the pharmaceutical industry required.
• 8 or More Years in regulatory affairs
• Experience in providing regulatory strategic input into the drug development process...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
pharmaceutical industry experience required
• 4 or More Years of direct regulatory affairs experience, including US labeling experience required
• Experience with ex-US labeling (outside the US) preferred
Travel - Ability to travel up to 10%
Daiichi Sankyo, Inc...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection
• Supports Regulatory affairs...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
centered around rare diseases and immune disorders.
Summary
This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member and independently provides strategic and operational...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with CROs, License Partners, and PV vendors. Provide PV oversight of the DSI Call Center. Provide oversight of ICSR processing activities including, Safety...
jobg8.com -
Daiichi Sankyo, Inc.-Newark
Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics...
jobg8.com -
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