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...
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 RA Associate Director, Labelling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, ...
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...
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...
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, ...
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...
The Senior Manager or Associate Director for BBOT Regulatory Affairs will be a strategic thinker responsible for overseeing regulatory assessments and research on regulatory precedence to evaluate strategies for precision medicine development programs. Senior Manager or Associate Director, Regulator...
The Associate Director, Medical Writing (Regulatory) will collaborate with colleagues to write high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US ...
The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related to...
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 RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
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...
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...
This role reports to the Senior Director of Regulatory Compliance. Research and advise on regulatory compliance issues that impact Lyft’s Operations, Marketing, Finance and Product teams. Communicate regulatory compliance requirements and offer guidance to other teams including Communications, Produ...
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...
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 ...
The Associate Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-...
The Associate Director, Analytical Regulatory Science, collaborates with product. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support “right first time” global approvals for CMC control strategies and maintai...
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...
Aramis Frost is partnering with a leading Biotech specializing in Oncology to find an Associate Director of Regulatory Medical Writing. In this pivotal role, you will oversee the regulatory writing strategy and contribute significantly to the development of cutting-edge oncology therapies. You will ...
The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Regulatory Affairs (RA) Associate Director, L...
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...