A company is looking for an Associate Director, Regulatory Affairs and Submissions. ...
Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
A company is looking for a Regulatory Affairs Senior Associate to support regulatory document management and clinical trial submissions. ...
Our client, a prestigious Am Law 100 firm, is seeking an Associate Attorney to join their projects team! This team is recognized as Band 1 in all relevant categories by Chambers. Address regulatory aspects of developing, financing, buying, and selling a diverse range of energy projects across the co...
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. ...
Chemistry or equivalent degree plus 10 years industry experience directly in Regulatory Affairs or in CMC and clinical regulatory or role with regulatory submission responsibilities. This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturin...
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 ...
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 ...
Author and/or review high quality CMC sections for global regulatory submissions (IND/CTA, and BLA/MAA), applying agreed CMC global regulatory strategies, current regulatory trends, and guidelines. Provide regulatory review and impact/implementation assessment of proposed Change Control records and ...
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...
Regulatory Affairs Associate, CMC. Represent Regulatory Affairs (RA) CMC on product development and life-cycle management teams to identify critical issues, negotiate, influence, and provide strategic advice to peers in Pharmaceutical Development and Manufacturing, RA, and Regulatory Operations. Sta...
Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required. Job Title: CMC Regulatory Affairs, Data Entry Contractor Position. Work collaboratively to support the team by executing routine data entry, such as the input of submission related...
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...
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...
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...
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. ...
About the role:Allogene is seeking an Associate Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams. Reporting to the Head of Regulatory Affairs, th...
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 ...
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...
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)...
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...
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 ...
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...
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 ...