Role Overview Responsible for all regulatory affairs activities required to support lead, manage, review, and submit... compliance. Primary Duties & Responsibilities Regulatory Affairs: o Lead and manage all regulatory affairs-related...
business. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development... through the recruitment of Regulatory Affairs Strategists. With us, you will get the opportunity to work across the spectrum...
Director - Regulatory Affairs Location: Branchburg, NJ Type: Direct Hire We are partnering with a leading... pharmaceutical company to identify a highly qualified Director of Regulatory Affairs to drive regulatory strategy, submissions...
. Job Description The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and overseeing data... governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset...
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...
on , , , , and . Job Description The Associate Director Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external... partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals...
Job Title: Director, CMC Lead Drug Development Job Location: Gaithersburg, MD, USA Job Location Type: Remote... demands. Prepare, in conjunction with Regulatory Affairs, the Chemistry and Manufacturing Controls sections of all IND...
with no prescribed procedures to solve complex problems. Global Regulatory Affairs CMC strategy, with hand-on CMC authoring.... Every day, we rise to the challenge to make a difference and here’s how the Director, Global CMC Strategy (Eye Care) role...
will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs... Description Latigo is searching for a Senior Scientist, CMC Analytical Chemistry. Reporting to the Director of Analytical Chemistry, the...
approvals to market our products. The individual will represent Regulatory Affairs and work closely with cross-functional teams... to the Executive Director and Head of Regulatory Strategy. ESSENTIAL DUTIES & RESPONSIBILITIES Develop and implement...
that regulatory strategies are in alignment with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial...Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can...
purpose of the Senior Director/Executive Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop... experience in regulatory affairs and/or drug development experience for 10 years Direct experience in clinical and CMC...
a highly experienced Senior Director of Regulatory Strategy to join a leading pharmaceutical company in Pennsylvania on a 12... in regulatory affairs, ensuring compliance with FDA and global regulatory requirements. Key Responsibilities: Develop...
(Global Regulatory Portfolio Leader), Global Regulatory Affairs (GRA), Specialty Business (Brands and Innovative Medicines... in one and (typically) more geographies. The role will be a key member of the Global Regulatory Affairs Leadership Team (GRA LT), reporting...
and supplemental applications. Ensure that regulatory strategies are in alignment with product portfolio, regional strategies, CMC...-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile (for global programs...
as an Associate Director, Regulatory Project Management. The Associate Director, Regulatory Project Management will manage Cartesian...'s regulatory portfolio of US and ex-US filings, supporting both the clinical and CMC regulatory leaders. Key Responsibilities...
with product portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target...Johnson & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Leader. This position can...
functions autonomously, with minimal supervision. Global Regulatory Affairs CMC strategy, with hand-on CMC authoring.... Every day, we rise to the challenge to make a difference and here’s how the Director, Global Regulatory Strategist (Eye Care...
/manufacturing, quality control, quality assurance, supply, regulatory affairs Provide lyophilization subject matter expertise... Biotechnology is looking for an experienced Associate Director to join Drug Product Process Development and Formulation group. The...
Director, GMP QA, reporting to the Director of GMP Quality Assurance. The role will work closely with the CMC Team to ensure... quality oversight of external vendors and contract manufacturing organizations (CMOs). The Associate Director...