The Associate Director – CMC Regulatory is responsible for leading global CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific CMC regulatory impact of change ...
The Associate Director, Regulatory Affairs will be responsible for supporting the development and implementation of global Chemistry, Manufacturing and Control (CMC) regulatory strategies and managing the preparation of supporting documents. Fore Biotherapeutics is seeking an experienced and highly ...
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
Anticipate regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issu...
She/he utilizes in-depth knowledge of global regulatory submission requirements and works collaboratively within Regulatory Affairs and other cross-functional departments in providing guidance towards achieving department application filing objectives, identifying areas of concern that are impacting...
The Associate Director of Global Regulatory Affairs CMC is responsible for the development and execution of global Chemistry, Manufacturing, and Control (CMC) regulatory strategies that support the success of products throughout their lifecycle. This role provides regulatory guidance to various cros...
As a Regulatory Compliance and Operational Risk Senior Associate, you will get the opportunity to grow and contribute to our clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Risk Advisory Practice – all ...
This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment. Reporting t...
RSM's AML/Regulatory Compliance group is currently seeking a strong resource to join our fast growing Risk Consulting practice at the Senior Associate level. This position will lead and deliver regulatory compliance internal audits, assessments, model validations and other services at client locatio...
Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments) Perform life cycle management for marketed products on a global basis, including regulatory impact assessments and preparation of CMC documentation for va...
The Project Manager, IT Specialist LIMS will play a crucial role in ensuring the successful execution of IT projects related to Laboratory Information Management Systems (LIMS), Regulatory Information Management Systems (RIMS), and biostatistics analysis systems. Project Manager, IT Specialist/LIMS....
Milligan & Company, LLC, a full-service Consulting and Certified Public Accounting firm has developed highly specialized niche practices in the areas of: Government Compliance and Oversight; Economic Development Consulting; Supplier and Workforce Diversity; and Equal Opportunity and Affirmative ...
The Compliance Specialist supports the EARN Program through compliance management, assisting in the maximization of efficient and effective service delivery to EARN customers working closely with Workforce Advisors and the Data Team to ensure clear communication between departments for timely follow...
Director of Regulatory Affairs Strategy. Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Work with various departments to formulate and execute effective Regulatory Strategies, assessin...
The Senior Director, Regulatory Affairs, Advertising and Promotion is responsible for providing commercial regulatory strategy and direction to enable the business to meet its commercial needs in support of patients and in a compliant manner. Assume a leadership role in advising cross-functional sta...
Position Summary:Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keeps ...
By managing capital programs and projects as if they were our own, our project management business, and technical experts work with clients to strategize, plan, and implement projects that help them achieve their organization's objectives. Stantec seeks an Owner's Representative, at the Project Mana...
As part of the Marketing Advisory team, you will have in depth hands-on marketing skills with a breadth of understanding of how marketing and Medical, Legal, Regulatory processes works and draw on these skills as a trusted advisor who guide Life Sciences clients through transformation and toward gro...
Liaises cross-functionally with partners in Commercial, Medical Affairs, Regulatory, Legal, Public Relations, and others to develop holistic strategies around communication initiatives, working within the regulatory framework and boundaries. Provides leadership within the Regulatory department, iden...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 - $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
The EEOC and Data Privacy Compliance Specialist is responsible for ensuring the accurate collection, review, and submission of employee data to the Equal Employment Opportunity Commission (EEOC) and other government agencies, as well as supporting the development, implementation, and maintenance of ...
The Corporate Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. Senior Clinical Informatics Specialist. ...
Project Manager - OSP Construction Fiber Construction experience for a Direct-Hire role in the Harrisburg, PA area (Central Pennsylvania or South central, PA). Project Manager you will be responsible for ensuring the deployment of fiber primarily in Central Pennsylvania or South-central PA area. Pro...
This position has several primary functions and/or responsibilities:1) Responsible for developing and executing process validation protocol for aNDA product.Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product.Initiate investigation in prob...
Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI/NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB/CIRB, CTSRMC, and all applicable regulat...