This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest qua...
Under the direction of the Senior Director or Executive Director, Global Regulatory Affairs provides strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activ...
Responsible for the design, implementation and quality oversight of major regulatory programs as defined and agreed upon with the Senior Director of the Clinical Trial Operations and the Principal Investigator of InCHOIR. InCHOIR faculty are expert in study design, clinical coordination, regulatory ...
The Senior Director of CMC Regulatory Affairs for Biopharm products is an experienced and seasoned CMC Regulatory professional specializing in post-approval activities for Biopharm products. As part of the Global CMC Regulatory team, you define the CMC regulatory strategy in partnership with main st...
As the Senior Director of Regulatory Affairs, you will spearhead the development and execution of a dynamic global regulatory strategy for food and biopesticide/biostimulant products, facilitating business growth through gaining market permissibility while ensuring compliance and risk management. Re...
Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams. Regulatory Affairs Labeling works closely with cross-functional partners to ensure timely and appropriate delivery of product ...
Quality Associate Director of Regulatory Affairs and Regulatory Intelligence. Strong knowledge of Regulatory Affairs and years of experience in a Regulatory Intelligence position*. The Quality Associate Director Regulatory Intelligence. Promote regulatory compliance expertise, both externally and in...
Provides high level strategic and operational regulatory direction and leadership on projects including, but not limited to, North America regulatory strategies, regulatory requirements for clinical studies and marketing approval in the NA markets, regulatory strategic development plans and risk ass...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Must perform tasks directed by manager . ...
Our client is looking to fill the role of CMC Regulatory Affairs Manager. Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus). Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related su...
The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products. The Execut...
Ensures compliance with Deringer specific policies and procedures, based on department’s specific tasks. Previous technical/compliance background and language skills are a plus. ...
Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. Represents CMC RA in project team meetings and provides regulatory guidance and perspective to t...
Become an authority on all things IT audit and compliance. Translate business and control requirements into the design of features and enhancements in our compliance tools. At HubSpot, fair compensation practices isn’t just about checking off the box for legal compliance. ...
Work with Department Manager to assist with the continuous process improvement of the department. Strong background in process design and project management. ...
We are inviting professionals in high-growth industries who are thinking about their next move or looking for a new opportunity to join our expanding talent pool.The Marlee Talent Pool is a pilot project designed to:.Help job seekers get discovered by our partners based on their anticipated hiring n...
Assists and supports the organization in complying with, as well as the ongoing preparation and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies. May serve as point of contact for interactions with regulatory agencies for defined matters. Performs t...
Accountability for the delivery of the portfolio of projects, direct responsibility for the team of employee and consultant project managers leading the projects, and responsibility for the UW Medicine staff and consultants who make up the project teams. The portfolio of projects under the Manager's...
The Regulatory Affairs Specialist is responsible for regulatory activities to support new, modified and currently marketed medical devices in the company’s line of products. Regulatory Affairs Specialist II - Hannah. This includes the preparation of regulatory documentation for submission to regulat...
Typical projects range from preparing air permit applications, conducting compliance audits, preparing emission reports, conducting air quality applicability assessments, program development, regulatory analysis and reporting, and database solutions for air quality compliance requirements at the loc...
As the Executive Director, Global Commercial Lead, TEVIMBRA, you will play a critical leadership role in BeiGene’s newly-formed Global Commercial Strategy & Operations team. Represent ONE commercial voice to Global Product Team (GPT), R&D, Tech Ops, Executive Leadership, and Disease Area Teams to dr...
We are seeking an Associate Director, Social Media - Executive Thought Leadership to join our growing team. The Associate Director will be responsible for supporting social media and content strategy for our Social Media Executive Thought Leadership Team clients. Provideday-to-day social media suppo...
Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Reviews regulatory impact assessments drafted by RA staff for manufacturing and product changes for notification to regulatory agencies. Prepares regulatory plans and prepares needed regulatory submissions and as...
Interface with suppliers along with industry partners to ensure products and components meet regulatory compliance. Produce and maintain required compliance certificates, test reports to show conformance to regulatory requirements. Support regulatory compliance process improvement activities . Exper...