Assist Regulatory Manager in maintenance of customer regulatory files and raw material files. Obtain technical/regulatory documentation from raw material vendors. Helps manage regulatory compliance related to EU PIF/dossiers. Maintain regulatory files for each ingredient (TDS, SDS, CofA, ingredient ...
My client is working towards their first ever NDA and seeking an Associate Director/Director Regulatory Advertising and Promotions/Labeling to join their growing Regulatory team. Provide leadership for and manage regulatory aspects of the copy review / approval process for promotional materials; ens...
Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to support regulatory submissions and responses to regulatory agencies. They are seeking a highly skilled and experienced an Associate Director OR Director, ...
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...
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. ...
JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. In this role you will play a key role in planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines. Account...
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 hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. Autonomously...
Our client is seeking an experienced Engineering Project Manager to join their dynamic Engineering Team in Southern California. Manage all project phases, from initial investigation through to construction and remediation, including drafting detailed drawings, plans, specifications, reports, bid doc...
The ideal background in a Consultant will be a Product Owner, Business Analyst or Business Systems Analyst turned Product Analyst with domain experience in Governance, Risk, and Compliance and/or Financial Crimes. Product analyst/business systems analyst experience in Agile framework and toolset. Pr...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
Director/Senior Director, Regulatory Affairs. They are looking for a Director or Senior Director of Clinical Regulatory Affairs to join their team. Develop and execute Clinical Regulatory Affairs strategies to support clinical development objectives. Minimum 7 years specifically in clinical regulato...
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. ...
Senior Director/Executive Director, Regulatory Affairs. Meet has partnered with a pre-IPO biotech that is looking for a Head of Regulatory Affairs to join their team. Develop and execute regulatory strategies to streamline the development and approval of innovative medicines. Lead the preparation of...
CM Medical is partnered with an exciting Cardiac EP start-up who are seeking a Director of Regulatory Affairs to lead regulatory strategy and compliance efforts for their devices. Lead and mentor the regulatory affairs team. Develop and implement regulatory strategies for new and existing products. ...
Administrative Analyst/Specialist - Exempt II. Fiscal Processing & Reporting Coordinate and conduct financial aid fiscal processing activities to ensure proper stewardship of funds and compliance with all regulatory guidelines. Develop and maintain internal control processes to ensure proper steward...
Compliance & Ethics Specialist. Perform field and desk monitoring to ensure compliance with to relevant laws and regulations. Track, analyze, and report on compliance monitoring progress, identifying trends and potential risks. Provide compliance guidance and support for various initiatives and proj...
We are seeking an experienced and detail-oriented Senior Regulatory Specialist to work on a core project team which will author an original Premarket Approval (PMA) application for a Class III neurovascular device. The successful candidate will play a crucial role in ensuring that our innovative med...
Regulatory Affairs AD/Director – Labeling. This person will oversee the US Regulatory Labeling activities and processes for regulatory submissions and product maintenance. The RA AD/Director will be responsible for building the team and then leading and managing its growth and development. ...
Regulatory Affairs Manager - Permanent - San Francisco Bay Area. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product int...
Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. The position is responsible for providing...
This position will be responsible for developing and executing regulatory strategies for early-phase programs and IND submissions. ...
The Trade Compliance Specialist is responsible for handling complex export and/or import situations with oversight and guidance from management. Responsibilities include coordination with staff that perform transaction processing and transaction due diligence, analysis of red flags, complex troubles...
They are looking to bring on an Executive Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requi...
The Senior Labor Compliance Specialist will provide overall compliance support to projects requiring prevailing wage and other specific labor requirements. Certified Labor Compliance Specialist (CLCS) or similar certification is a plus. Be responsible for labor compliance company-wide. Perform perio...