A company is looking for an Associate Regulatory Coordinator. ...
Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory Affairs. The Associate Director, Analytical Regulatory Science, collaborates with product. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibili...
A company is looking for a Regulatory Affairs, Senior Associate. ...
As an Associate General Counsel in the Litigation and Regulatory Practice Group, you will report to the Head of the practice group (who is based in San Jose), and work closely with all members of the Global Legal team and business leaders throughout the company. The right candidate will have a basic...
A company is looking for a Senior Associate Regulatory Affairs for a remote position. ...
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, ...
This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions. This Associate Director will coordinate activities with internal team members and external parties (e. Ma...
Regulatory Affairs Associates (Data),. Job Title: Regulatory Affairs Associates (Data). Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general s...
Assist Regulatory Manager in maintenance of customer regulatory files and raw material files. Obtain technical/regulatory documentation from raw material vendors. Helps manage regulatory compliance related to EU PIF/dossiers. Maintain regulatory files for each ingredient (TDS, SDS, CofA, ingredient ...
Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general supervision of more senior Regulatory Affairs CMC Systems professionals. ...
CMC Regulatory Technical Writer, Associate Director/Director. CMC technical document review and writing, authoring and compiling the CMC sections for global regulatory filings by working closely with the cross-functional teams including CMC, Quality, Clinical and Regulatory Affairs to ensure all CMC...
My client is working towards their first ever NDA and seeking an Associate Director/Director Regulatory Advertising and Promotions/Labeling to join their growing Regulatory team. Provide leadership for and manage regulatory aspects of the copy review / approval process for promotional materials; ens...
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, ...
Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to support regulatory submissions and responses to regulatory agencies. They are seeking a highly skilled and experienced an Associate Director OR Director, ...
Regulatory Affairs CMC – Data Administrator Contractor. Work collaboratively to support the RA CMC team to meet deliverables and timelines by executing routine data entry, quality control of that data entry and associated reports. Work is performed under the general supervision of more senior Regula...
Title: Regulatory Affairs Associate - II*. Analyzed and adapted to scientific and regulatory developments, implementing strategic adjustments in response to the global regulatory landscape. Facilitated cross-departmental collaborations, enhancing the efficiency and timeliness of regulatory submissio...
Experience with regulatory submissions and maintaining regulatory documents. ...
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 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...
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...
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...
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 ...
Regulatory Affairs Associate . ...
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...