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, ...
Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational products for US, Asia and LATAM and marketed products for US in line with ICH requirements, regional requirements and scientif...
Associate Director, Regulatory Affairs Advertising and Promotion. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. RA Ad/Promo provides strategic regula...
The Associate Director, Analytical Regulatory Science, collaborates with product development, manufacturing, and quality teams on the construction, documentation, and defense of the analytical control strategies in regulatory submissions preparation and review. By balancing analytical knowledge and ...
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 ...
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function wi...
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...
This position will be responsible for supporting the maintenance of the Global Regulatory Affairs filing system and the Registration Tracking System (RTS) database. This individual will be key to the continued compliance of the regulatory and labeling documentation. Maintain the Global Regulatory Af...
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 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 ...
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...
Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsJob Description. The Associate Director, Analytical Regulatory Science, collaborates with product development, manufacturing and quality teams on the construction, documentation and defense of the 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...
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, ...
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...
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. ...
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...
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 ...
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...
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 ...
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...
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...
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...
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...