A company is looking for a Senior Associate, Regulatory Operations. ...
Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
A company is looking for a Regulatory Consulting Associate responsible for preparing plan documents and providing regulatory compliance support. ...
Regulatory Affairs Associate, CMC. Sr Associate, Regulatory Affairs, CMC. Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify the critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufa...
A company is looking for an Associate Director, Global Regulatory Project Management and Strategic Planning - GI. ...
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 ...
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...
Help determine regulatory strategies for manufacturing changes and regulatory activities. A Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with - years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship)...
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 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 ...
Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research. Independently provide strategic guidance/input related to current regul...
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...
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 ...
Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. Associate Director / Di...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Bachelor’s degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internshi...
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...
The Senior Regulatory Associate role will be working with regulatory operations as well as regulatory affairs on submission preparation to global regulatory authorities. Specifically, this role will work closely with the Regulatory Operations Manager and the Regulatory Leads to support day-to-day ac...
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. Associate Director, Regulatory Affairs Advertising and Promotion. Regula...
Regulatory Affairs Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. A Master’s Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track workflows for regulatory submissions. ...
Regulatory Affairs Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. A Master's Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track workflows for regulatory submissions. ...
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...
Assist in preparing product dossiers for regulatory submission to regulatory. Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements as well as development projects. You will be the primary contact and provid...
Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage the associated regulatory notifications. Serve as the primary liaison with internal stakeholders and external collaborators on regulatory responsibilities and ensure timely support of regulat...
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...
Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regulatory Affairs with a minimum of months of regulatory experience (internship) is required. Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regul...