For the expansion of our team, argenx is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. Author clinical content and project manage SME contribution of regulatory documents to dev...
Natural Gas Regulatory Analyst, Associate. Job Category: Government and Regulatory Relations. CGS comprises an exciting and fast paced team which offers many learning opportunities through exposure to Regulatory Approval processes, Asset Acquisition, Trading, Portfolio Planning and Analytics, Risk a...
Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, ...
Reporting directly to the SVP General Counsel/Chief Compliance Officer, the Associate General Counsel - Regulatory, Compliance, and IP (AGC) will establish strategy and provide legal advice and counsel relating to several subject matter areas, including FDA/TFC laws and regulations, intellectual pro...
Senior Associates, Associates, and Sr. Norton Rose Fulbright is seeking an associate with 4-8+ years of legal experience with respect to FERC electricity, with some exposure to project finance or project documents for energy transactions. The work will involve regulatory aspects of the development, ...
One of Fortune’s Best Places to Work, Perkins Coie, LLP, a leading international law firm, is seeking an FDA regulatory associate. FDA and USDA regulatory matters at another leading food and drug practice, at the FDA, the USDA, or in-house. Experience in food regulatory matters is strongly preferred...
The Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer-related RA CMC compliance activities. Lonza Regulatory Intelligence Bulletin, interpretation of EU, US, and other global regulatory requirements to support compliance in all phases of ...
Mid-Level - Senior Financial Services Compliance And Regulatory Associate Attorney. A law firm in San Francisco, CA, is seeking a highly skilled and experienced Mid-Level - Senior Financial Services Compliance and Regulatory Associate Attorney. This role provides expert legal counsel on regulatory a...
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Associate Director Regulatory Affairs – A...
Mid-level Associate – Environmental/Regulatory, Energy & Resources Associate - San Francisco, CA. The San Francisco office of Perkins Coie LLP is seeking a mid-level associate to join its highly regarded environmental/regulatory, energy and natural resources practice. California Public Utilities...
As a Regulatory Policy Associate at Astranis, you will work with every member of the regulatory team to help craft and execute our plan to license dozens of satellites and associated spectrum in the coming years. Draw conclusions from analyzed data and recommend associated actions to the Regulatory ...
Well versed in ICH guidelines for regulatory submissions (INDs/CTAs/BLAs/MAAs) and associated regulatory documents including clinical protocols/study reports and investigator brochures. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medi...
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs. Associate Director, Regulatory Affairs , you. Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout ...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
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...
You will provide regulatory support in development and execution of regulatory strategies in support of the global clinical trial applications, marketing authorizations, and life cycle management of an expanding oncology portfolio in compliance with applicable regulatory requirements. Ensures regula...
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Associate Director Regulatory Affairs – A...
Develop regulatory processes including GSRA standard operating procedures, policies, guidelines and/or chassis in compliance with applicable regulatory requirements and drive core training and documentation on regulatory processes, and other applicable regulatory operations requirements to maintain ...
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...
Internal regulatory support for operation and control eg:Review and approval of Lonza Regulatory Intelligence Bulletin, Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products and maintain transparency of ...
She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting...
The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop regulatory submission strategy, and provide executive management with regulatory metrics/information. Associate Director Regulatory Affairs – US New ...
Our firm is seeking a highly qualified associate with two to four years of health care regulatory experience to join our growing team. Our health care transactions and regulatory team assists with the structuring and negotiation of transactions, provides strategic advice on regulatory and compliance...
Our client is in search of candidates who demonstrate a keen interest and enthusiasm for tackling the intricate regulatory and policy challenges within the Medicaid program. This includes assisting with transaction structuring and negotiation, providing strategic counsel on regulatory and compliance...
Natural Gas Regulatory Analyst, Associate. Job Category: Government and Regulatory Relations . CGS comprises an exciting and fast paced team which offers many learning opportunities through exposure to Regulatory Approval processes, Asset Acquisition, Trading, Portfolio Planning and Analytics, Risk ...