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...
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, ...
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, ...
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 ...
Experience with regulatory submissions and maintaining regulatory documents. ...
The Own Brands Technical Services team has an opening for a Regulatory Affairs Associate. As part of the Regulatory Affairs team, the RA Associate will be responsible for ensuring faultless compliance of product labeling for several brands within Albertsons Own Brands. These activities include overs...
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. ...
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...
HIM Director(Regulatory Manager). Experience conducting training for quality assurance and/or regulatory affairs. Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred. Hiring Manager has rejected all the candidate ...
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...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affair...
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...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
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...
Regulatory Affairs AD/Director – Labeling. This person will oversee the US Regulatory Labeling activities and processes for regulatory submissions and product maintenance. The RA AD/Director will be responsible for building the team and then leading and managing its growth and development. ...
Senior Director, Regulatory Affairs. Meet has partnered with a late-stage oncology biotech based in the Bay Area that is looking for a Senior Director of Regulatory Affairs to join their team! Our client has a very developed late-stage oncology pipeline, with multiple P2 and P3 trials. You will lead...
Optima Partners is looking for graduates or recent graduates to join our Los Angeles or San Francisco office as a Compliance Analysts, supporting our Senior Compliance Consultants in developing, implementing and maintaining compliance programs for a variety of registered investment management firms....
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Ability to interpret and apply regulatory requirements....
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 ideal background in a Consultant will be a Product Owner, Business Analyst or Business Systems Analyst turned Product Analyst with domain experience in Governance, Risk, and Compliance and/or Financial Crimes. Product analyst/business systems analyst experience in Agile framework and toolset. Pr...