A company is looking for a Quality Associate Director of Regulatory Intelligence. ...
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 ...
A company is looking for an Associate Regulatory Coordinator. ...
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, ...
A company is looking for a Senior Associate Regulatory Affairs for a remote position. ...
Experience with regulatory submissions and maintaining regulatory documents. ...
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. ...
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...
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...
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 Associate . ...
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...
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...
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, ...
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 ...
A law firm in Mountain View, CA, is seeking a Senior Health Care Regulatory Associate Attorney with 3+ years of experience in health care regulatory matters. Senior Health Care Regulatory Associate Attorney. Intellectual Property Associate – Trademark, Copyright, Advertising and Media AssociateSan F...
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...
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-...
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. ...
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...
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...
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 ...