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. ...
(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...
Associate Regulatory Affairs
A company is looking for an Associate, Regulatory Affairs to join their Compliance team. ...
Regulatory Senior Associate
The Senior Regulatory Affairs Manager is responsible for the assessment of regulatory permissibility and suitability of the H&W portfolio and the successful interaction between the global RSA community and cross-functional teams to ensure regulatory compliance of the products in the North American M...
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 Program Manager, Regulatory Affairs - Labeling (REMOTE).
Demonstrated successful leadership experience, including in multi-functional teams including Global Sales & Marketing (GSM), Regulatory, Legal, Clinical/Medical Affairs, Quality, Corporate Communications, and other Functional Departments. Advanced experience with regulatory review of labeling · Expe...
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...
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...