Regulatory Affairs Specialist
2 days ago
At Daiichi Sankyo Group, we are dedicated to creating innovative pharmaceutical therapies to improve standards of care and address unmet medical needs globally. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.
Job SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products.
Responsibilities- Preparation of new and updated Core Data Sheets, EU and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., draft launch labeling, USPI, annotated labeling, medication guides, EU SmPC, EU PL, CCDS, CCPL) for new products or products in the development phase.
- Ensure Compliance with Core Data Sheets/Label Changes: Develops and communicates strategic labeling development strategic plan to other project team members and ensures implementation of CCDS/labeling agreements with licensing partners.
- Conduct Label Review Committee Meetings: Prepares documents for review by labeling teams and leads review processes to ensure appropriate governance for US, EU and Company Core documents as well as for the review of country labeling deviations.
- Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings and manages compliance with internal and external guidelines.
- Bachelor's Degree preferably in a scientific discipline required.
- Advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
- 10 or More Years pharmaceutical industry experience required.
- 4 or More Years of direct regulatory affairs experience, including CCDS and US/EU labeling experience required.
Ability to travel up to 10% Occasional travel.
-
Regulatory Affairs Director
2 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryThe Senior Manager CMC Regulatory Affairs will lead the regulatory strategies for biologic products and combination products for the product portfolio assigned.Key ResponsibilitiesResponsible for CMC/CP product development activitiesRegulatory Affairs, Manager, Regulatory, Senior, Communications, Product Development, Business ServicesWhat You'll...
-
Regulatory Affairs Director
1 week ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeUnlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a global pharmaceutical innovator with a rich legacy of innovation and a robust pipeline of promising new medicines. We are seeking a highly skilled Regulatory Affairs Director to join our team and contribute to our mission of delivering innovative treatments for patients with cancer.Key...
-
Regulatory Affairs Director
2 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Regeneron Pharmaceuticals. As a key member of our regulatory affairs team, you will be responsible for providing leadership on global regulatory activities for our assigned products.Key ResponsibilitiesProvide interpretation of regulatory authorities' feedback,...
-
Senior Manager CMC Regulatory Affairs Lead
2 weeks ago
Basking Ridge, New Jersey, United States Regeneron Pharmaceuticals Full timeJob SummaryWe are seeking a highly experienced Senior Manager CMC Regulatory Affairs to lead our regulatory strategies for biologic products and combination products.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned product portfolioLead CMC/CP product development activities in Regulatory AffairsCollaborate with cross-functional...
-
Regulatory Affairs Director
2 weeks ago
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob SummaryThis role offers the opportunity to contribute to the mission of Daiichi Sankyo in leveraging innovative science and pushing beyond traditional thinking to create meaningful treatments for patients with cancer. The successful candidate will work on one of our cutting-edge assets by effectively liaising, negotiating, and partnering with FDA. This...
-
Global Regulatory Affairs Labeling Expert
1 week ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryWe are seeking a highly skilled Global Regulatory Affairs Labeling Expert to join our team at Daiichi Sankyo, Inc. This role will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products.Key...
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob DetailsTransforming Healthcare through Innovative Regulatory StrategiesDaiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With a rich legacy of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 16,000...
-
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to delivering high-quality products that meet the evolving needs of healthcare professionals and patients.Job SummaryWe...
-
Business Systems Analyst
4 weeks ago
Basking Ridge, New Jersey, United States Insight Global Full timeJob SummaryWe are seeking a highly skilled Business Systems Analyst to join our team at Insight Global. As a Business Systems Analyst, you will play a critical role in supporting the delivery of GxP validated global business systems serving cross-functional stakeholders.Key ResponsibilitiesPartner with business stakeholders to architect and implement...
-
Basking Ridge, New Jersey, United States BioSpace, Inc. Full timeJob DetailsJoin a Legacy of InnovationDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more...
-
Regulatory Tax Compliance Specialist
2 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeJob Title: Regulatory Tax Compliance SpecialistWe are seeking a highly skilled Regulatory Tax Compliance Specialist to join our team at Verizon. As a key member of our compliance team, you will be responsible for ensuring that our company's tax compliance processes are accurate, efficient, and in line with regulatory requirements.Key Responsibilities:Prepare...
-
Regulatory Tax Compliance Specialist
2 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeJob Title: Regulatory Tax Compliance SpecialistAt Verizon, we are committed to providing the highest levels of compliance. We are seeking a highly skilled Regulatory Tax Compliance Specialist to join our team.Responsibilities:Prepare and file all video franchise and PEG filings accurately and timely in accordance with all laws and regulations for all...
-
Regulatory Tax Compliance Specialist
3 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeJob Title: Regulatory Tax Compliance SpecialistAt Verizon, we are committed to providing the highest levels of compliance. As a Regulatory Tax Compliance Specialist, you will be responsible for preparing Video Franchise and PEG filings with various Local Franchise Authorities utilizing financial systems to analyze data, compute payments and file returns...
-
Regulatory Tax Compliance Specialist
3 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeAbout the RoleWe are seeking a highly skilled Regulatory Tax Compliance Specialist to join our team at Verizon. As a key member of our compliance team, you will be responsible for preparing and filing video franchise and PEG filings with various local franchise authorities.Key ResponsibilitiesPrepare and file all video franchise and PEG filings accurately...
-
Director of State Government Relations
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJob SummaryWe are seeking a highly skilled and experienced professional to join our team as a Director of State Government Affairs. This role will be responsible for leading our engagement across the United States to ensure patient access to our current portfolio and robust pipeline of medicines.Key ResponsibilitiesDevelop, lead, and prioritize Daiichi...
-
Associate Director, Labeling Expert
2 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob Title: Associate Director, Labeling ExpertJob Summary:We are seeking an experienced Associate Director, Labeling Expert to join our Global Regulatory Affairs team. The successful candidate will be responsible for providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This role will manage...
-
Senior Tax Compliance Specialist
4 weeks ago
Basking Ridge, New Jersey, United States Verizon Full timeJob SummaryWe are seeking a highly skilled Senior Tax Compliance Specialist to join our team at Verizon. As a key member of our tax compliance team, you will be responsible for preparing and filing state and local regulatory filings and business licenses, while ensuring adherence to regulatory compliance laws and local business license ordinances.Key...
-
Clinical Science Group Lead
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeJob SummaryWe are seeking a highly experienced Clinical Science Group Lead to join our team at Daiichi Sankyo, Inc. This is a critical role that will lead the development of our late-stage clinical studies and ensure the highest scientific and medical standards are met.Key ResponsibilitiesDevelop and execute the global clinical science strategy for...
-
Director, Informatics Solutions
4 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced Director, Informatics to join our team at Daiichi Sankyo, Inc. as a key member of our Research and Development (R&D) organization.Key ResponsibilitiesInformatics Systems Development and ImplementationDevelop and implement R&D informatics systems and programs to support business functions,...
-
Cybersecurity Specialist
4 weeks ago
Basking Ridge, New Jersey, United States Clarity Recruiting Full timeJob Summary:Clarity Recruiting is seeking an experienced Cybersecurity Specialist to join our team in a full-time role. As a key member of our IT department, you will be responsible for resolving security-based issues, alerts, and troubleshooting in a Microsoft environment.Key Responsibilities:Develop and maintain Microsoft O365 Suite policies and Mobile...