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...
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 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...
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, ...
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...
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 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 ...
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...
Seeking a Regulatory Compliance Associate. This person will be responsible for being a liaison between operations teams and the broader Regulatory Compliance team to ensure the forecasting, assembling, tracking, filing, and overall organizing of regulatory applications critical for company success 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 ...
Chemistry or equivalent degree plus 10 years industry experience directly in Regulatory Affairs or in CMC and clinical regulatory or role withregulatory submission responsibilities. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing...
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...
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...
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-...
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, 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...
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 ...
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 ...
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...
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...
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...
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...
Medical Writing is a global, dynamic, and diverse team residing within Global Regulatory Affairs. We work collaboratively to advance the strategy and create high-quality documents for successful regulatory submissions, by bringing our passion for science, discovery, and innovative strategic thinking...