A company is looking for a Senior Regulatory Affairs CMC Associate.Key Responsibilities : Support management of CMC dossier content submissions for clinical and commercial applicationsIndependently plan and prepare routine clinical trial application related amendments and commercial submissionsMaintain submission trackers for coordination of submissions across multiple productsRequired Qualifications : BS degree required;
advanced degree (PharmD, PhD, Master's) preferredMinimum 5 years' experience in regulatory affairs or related function in drug / biologic developmentExperience in managing regulatory submissions for investigational or marketed products in eCTD formatUnderstanding of US and Ex-US regulations in drug / biologics developmentFamiliarity with ICH eCTD structure and major market post approval change requirements
Senior Regulatory Affairs CMC Associate
A company is looking for a Senior Regulatory Affairs CMC Associate. ...
Senior Project Manager - Rates and Regulatory (Remote) Share LinkedIn
The ongoing pace of regulatory uncertainty and economic volatility is unrivaled in the utility industry and requires equally unparalleled flexibility in ratemaking and regulatory strategies. GDS has been at the forefront of industry rate and regulatory policy, offering broad expertise in regulatory ...
Senior Regulatory Associate US Regulatory Affairs
A company is looking for a Senior Associate in US Regulatory Affairs. ...
Associate Director, US Regulatory Affairs Strategy
The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leadi...
Associate Regulatory Affairs
A company is looking for an Associate, Regulatory Affairs to join their Compliance team. ...
Associate Director, Global Regulatory Affairs Labeling
This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). More Years of direct regulatory affairs experience, including US labeling expe...
(Senior) Manager, Regulatory Affairs Labeling
Manager, Regulatory Affairs Labeling – Permanent – Georgia, North Carolina or Massachusetts. Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company with locations in Georgia, North Carolina and Massachusetts. You will manage the creation and maint...
20758 Sr. Director, Quality Assurance & Regulatory Affairs
Organizational responsibilities include site Quality Assurance, Quality Control and Regulatory Affairs documentation, and regulatory inspection / customer audit liaison activities. Director, Quality Assurance & Regulatory Affairs Atlanta, GA. In this role, you will be responsible for the site Qualit...
Senior Director of Regulatory Affairs
Job Title: Senior Director of Regulatory Affairs</b> <p dir="ltr"><b id="docs-internal-guid-4636b625-7fff-3b67-69fb-958ac72d4292">Company: Augmentjobs</b></p> <p dir="ltr"><b id="docs-internal-guid-4636b625-7fff-3b67-69fb-958a...
Senior Counsel, Product and Regulatory Affairs (Liquidity)
You will play an immediate and direct role as Senior Counsel, with responsibility for: (i) supporting Circle’s Product Team in the development of novel digital asset products and (ii) offering clear, concise regulatory advice to Circle’s business teams relating to and international digital asset re...