Participates in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional which require some interactions with other members in the Regulatory department for investigational and commercial products in line with US and ICH requirements, regional requirements and sci...
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, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities. Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and reg...
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...
Prepare and coordinate regulatory submissions, including amendments, supplements, annual reports, and safety reports. Develop regulatory strategies for manufacturing changes and activities. Manage workflows for regulatory submissions, ensuring they meet global standards. Bachelor’s degree in a scien...
Document management including uploading and tracking regulatory files, archival of regulatory correspondences and maintenance of regulatory submission log according to established procedures. Liaise with the Global regulatory lead and provide regulatory guidance for assigned projects, as applicable....
The Associate Regulatory Affairs Manager will be responsible for completing the regulatory work for the Health and Biosciences business and applicable joint ventures, with a focus on food applications, for the U. The The Associate Regulatory Affairs Manager is responsible for regulatory document dev...
A client of Innova solutions is immediately hiring for a Regulatory Associate I. Help determine regulatory strategies for manufacturing changes and regulatory activities. Degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required. Coordinate and track w...
Job Title: Regulatory Affairs Associate. Help determine regulatory strategies for manufacturing changes and regulatory activities. A 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...
Regulatory Affairs Associate I External ID 33789473 Fremont, CA - ON SITE 22 month W2 contract (with potential to extend or transition to perm) Pay rate: $30-35/hour - Depending on Education and Experience Summary: Shift: 1st Shift: Mon-Fri, 8:00AM-5:00PM Responsibilities: Assist in preparing respon...
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...
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 part of the team that ensures our labels meet the user's needs, the Associate Regulatory Labeling Specialist will work closely with other departments across the organization, making this an entry-level position that offers a unique breadth of exposure to different medtech compliance and design fu...
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. ...
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...
Associate Director, Clinical Regulatory Affairs . This successful candidate will be proficient in the principles of scientific writing and will work cross?functionally, advising the team on regulatory expectations for document co...
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...
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, 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. 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...
Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in supp. ...
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...
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...