The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Sr Associate Regulatory Affairs - CMC. As an Sr Associate Regulatory Affairs - CMC, you will:. ...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
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. ...
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, ...
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...
Experience with regulatory submissions and maintaining regulatory documents. ...
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, ...
Senior Associate Regulatory Affairs; Thousand Oaks, CA; Lead the organization and preparation of the CMC (Chemistry, Manufacturing, and Controls) sections of global annual notifications to meet regulatory requirements. ...
The Senior Associate will be tasked with the organization, management, and execution of regulatory CMC projects, ensuring the successful support of regulatory submissions. Job Title: Senior Associate Regulatory Affairs – CMC. We are seeking a dedicated and experienced Senior Associate for their Regu...
Master's degree and years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Bachelor's degree and years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experien...
Job Title: Senior Associate, Regulatory Affairs. Join our Regulatory Affairs team as a Senior Associate and contribute to our ongoing projects. Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Provide Subject Matter Expertise in Veeva Vault Configuration and...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
Job Title: Regulatory Affairs Senior Associate. Join our dynamic, global team as a Senior Associate in Regulatory Affairs. You'll be working closely with our Regulatory Information Management and Systems (RIMS) team, contributing to our mission of delivering regulatory systems and processes that ens...
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 Senior Business Controls Specialist (Regulatory Management Team) will provide analytical support to Enterprise Credit (Commercial) Officers in executing internal control discipline and operational excellence related to FDPA (Flood Regulation) during the underwriting/monitoring process. Supports ...
Workers' Compensation Audit & Compliance Specialist. This position exists to ensure that claims are handled in compliance with the best practices and procedures compliant with applicable state laws. Designs and recommends compliance policies, processes and procedures for multi-jurisdictions stat...
They are looking to bring on an Executive Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requi...
The successful candidate will assist with program/project management, customer interaction, and systems engineering. ...
Senior Director/Executive Director, Regulatory Affairs. Meet has partnered with a pre-IPO biotech that is looking for a Head of Regulatory Affairs to join their team. Develop and execute regulatory strategies to streamline the development and approval of innovative medicines. Lead the preparation of...
Regulatory Affairs Manager - Permanent - San Francisco Bay Area. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product int...
A growing, clinical-stage biotechnology company focused on the development of novel patient-specific immunotherapy strategies for the treatment of cancers, is seeking a new Senior Director Regulatory Affairs. The client is seeking an autonomous, results-driven candidate who can lead cross-functional...
Senior Regulatory Affairs Leader. Currently seeking a new Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations. ...