and effectively as possible. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the... Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members...
and effectively as possible. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the... Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members...
a dramatic difference in patients' lives! Position Summary The Director, Regulatory Affairs will be responsible for developing... studies. This individual will be a key member of project teams and reports to the Head of Regulatory Affairs. The Director...
stakeholders. Liaise closely with other GRA teams such as non-clinical, CMC, Labelling and AdPromo through the Regulatory Matrix... science Five or more years of experience of all phases of the drug development process in regulatory affairs, including...
product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team... projects. Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company...
with health authorities. In conjunction with regulatory affairs leadership, they will develop strong relationships, collaborate... ability to apply their knowledge to daily work, and the ability to represent regulatory affairs as part of an interdisciplinary team...
management system. ORGANIZATION STRUCTURE The Senior Associate, Regulatory Operations/CMC reports into the Manager/ Director..., Regulatory Affairs and is based in Morristown, New Jersey. RESPONSIBILITIES Primary responsibilities of this role include the...
in a regulatory elective. Regulatory elective opportunities are offered in areas including CMC, Advertising and Promotion... partnership with Northeastern University, Vertex Pharmaceuticals Incorporated (Vertex) is offering a two-year Global Regulatory...
on , , , and . Job Description The Senior Director of CMC Dossier Leadership will lead an experienced team responsible for the creation and management... of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC Strategy and Portfolio...
to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. How you will contribute: Leads the Early... management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report...
as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves as ad hoc member... pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or PhD. with 6-8 years pharmaceutical...
Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader located in New... regulated industry At least 6 years of Regulatory Affairs experience required with focus on the NA region and FDA Experience...
Job Description The Executive Director, Device Quality & Regulatory will play a pivotal leadership role within the... organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including auto-injectors...
Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global Quality to monitor and influence the... Regulatory Advisor – Pharmaceuticals (Senior/Executive Director) OBJECTIVES/PURPOSE To define and implement an external...
The Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands... one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team (GRA LT), reporting...
Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader located in New... industry or health authority regulated industry At least 6 years of Regulatory Affairs experience required with focus on the...
The Senior Director (Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands... one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team (GRA LT), reporting...
, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and external stakeholders..., CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to DCR-PHXC...
, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver.../Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory...
with colleagues in CMC, QA, commercial, clinical, and regulatory affairs to ensure appropriate selection and oversight of vendors... across functions (CMC, Clinical Operations, Quality Assurance, Regulatory, Sales, and Finance); Works with finance/accounting...