Keeps abreast of regulatory compliance issues and assists in developing new Regulatory Department procedures, as needed. Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guide...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Sr Associate Regulatory Affairs – CMC - Biotech/R&D/Science. Sr Associate Regulatory Affair...
Someone who has good knowledge of Regulatory Affairs/Compliance. ...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
The Senior Associate will be tasked with the organization, management, and execution of regulatory CMC projects, ensuring the successful support of regulatory submissions. Job Title: Senior Associate Regulatory Affairs – CMC. We are seeking a dedicated and experienced Senior Associate for their Regu...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
Job Title: Senior Associate, Regulatory Affairs. Join our Regulatory Affairs team as a Senior Associate and contribute to our ongoing projects. Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Provide Subject Matter Expertise in Veeva Vault Configuration and...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Job Title: Regulatory Affairs Senior Associate. Join our dynamic, global team as a Senior Associate in Regulatory Affairs. You'll be working closely with our Regulatory Information Management and Systems (RIMS) team, contributing to our mission of delivering regulatory systems and processes that ens...
Incident Compliance Specialist. To support the services outlined above, R&D’s Incident Compliance Specialist will assist the department Supervisor with oversight of the Special Incident Report (SIR) Unit by providing ongoing training and development for personnel to ensure that department produc...
Lead project management from requirements definition through implementation for multiple technical projects. Mastery of advanced project management experience with project management tools (I. Strong project management skills - proven ability to manage multiple projects simultaneously in a highly ma...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
The Compliance Analyst is responsible for auditing internal compliance reports and client documentation to determine the loan’s eligibility for purchase on the secondary market by ensuring compliance with applicable regulatory requirements including company and investor overlays. Compliance and/or Q...
Work collaboratively to support the Regulatory Affairs CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. ...
Senior Regulatory Affairs Leader. Currently seeking a new Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations. ...
Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. Certification is a plus (such as RAC from the ...
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affair...
We are seeking a highly skilled and experienced Electrical Project Manager to lead and manage electrical construction projects in the Los Angeles area. The Electrical Project Manager will coordinate with clients, engineers, subcontractors, and other stakeholders to deliver successful electrical proj...
SEEKING COMMERCIAL DRYWALL PROJECT MANAGERS & ESTIMATORS. I am working with multiple well-respected, firmly established Commercial Drywall Contractors seeking experienced Project Managers and Estimators. Commercial Drywall Project Manager OR Estimator Experience Required. If you have the followi...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Duties and Responsibilities (may include some or all of the below): Fieldwork throughout the Central Valley As-needed biological surveys and environmental compliance services at construction sites Preparing and reviewing environmental documentation that will be used for both permitting and ens...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...