Job Postings

Date Posted

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Position

This position is in the R&D Regulatory Strategy Department. The successful candidate will work with R&D Regulatory Strategy and Clinical Development team members to prepare and submit complex clinical trial applications for Grifols clinical programs. They will also process, compile, submit, and maintain Regulatory Submission Documentation for global regulatory submissions to global Health Agencies in electronic and/or paper formats and in accordance with agency requirements and company timelines.

JobID: 441168

Our client’s machine learning platform enables them to identify novel and better drug candidates based on information from products that have failed in the clinic. Our client is seeking an accomplished drug development scientist with experience in leading program management from development candidate molecule through IND-filing. The (Sr) Project Manager will work with preclinical project teams and scientific leadership, and CROs developing TPP’s, and driving project strategy and execution. The ideal candidate will have filed at least one small molecule successful IND. Initially, the (Sr) Project Manager will take over project management of our client’s most advanced candidate. Our goal for the new hire is to successfully manage the project leading to an IND approval in the first year of employment.

JobID: 1119

The Senior Manager, Regulatory Affairs Development Strategy provides regulatory guidance necessary to support project development teams. This position is responsible for managing assembly of regulatory documents for review and submission to health authorities.

Job ID: SENIO001477

The Associate Director, Regulatory Affairs Development Strategy is a critical role in the Reata Global Regulatory team and will lead all the relevant regulatory activities related to the development, registration and maintenance of assigned programs. This role will support the development of regulatory product strategy and ensures the timely and high quality execution. The Associate Director may act as Global Regulatory Lead for assigned projects as appropriate.

Job ID:  ASSOC001475

The basic role is to provide CMC and regulatory expertise necessary to lead the development, implementation, and influence of CMC regulatory strategy for small molecule drugs including global marketing application submission strategy, clinical trial support, and CMC change management. RESPONSIBILITIES: Provide CMC regulatory support for new and ongoing clinical trials. Maintain current awareness of relevant global CMC requirements and identify and assess global regulatory risks and mitigation plans. Coordinate all CMC aspects of regulatory submissions, including strategy for updating existing dossiers, submission of new INDs/CTAs/NDAs/MAAs, etc. Provide hands-on support in generation of CMC documents (e.g., Module 2 and Module 3 of CTD, IMPD, etc.). Provide support for cGMP activities as they relate to regulatory affairs (e.g., inspections). Provide support for responding to queries from health authorities and for preparing for meetings with regulatory agencies.

JobID: ASSOC001469

The Regulatory Science Lead will prepare and deliver regulatory operational plans for assigned projects/products within a specific region. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

As a member of the Regulatory Affairs team, the individual will work directly with the global project teams creating documentation to support marketing applications and various other requirements of government agencies. This includes collaborating to gain the necessary approvals, licenses, and registrations required to place a new product on the US market and to maintain the required regulatory status of existing commercial products.

If interested, contact Jeanine Phillippie at [email protected]

Radiation Oncology has a portfolio of studies Phase I-III, across all disease sites in oncology. Studies involve investigational agents, chemo-radiation and device studies, mostly single site studies with some multi -site studies. Ideally the successful candidate will have oncology and/or research experience. The position demands a commitment to providing a high standard of care, to be flexible and adaptable to changes within the work environment on a regular basis, must be detail oriented, a critical thinker and be able to engage positively within a team dedicated to oncology research. Can easily use computing software and web-based applications (Microsoft Office products, EPIC, OnCore and IMedris and internet browsers). A minimum of 24 months of appropriate clinical nursing experience is required.

JobID: 170920

We are looking for an Assistant Research Practice Manager in the Duke Cancer Institute. The Assistant Research Practice Manager will provide upper level leadership and day-to-day management for the breast oncology team and will oversee all aspects of clinical trial management, including site management, data entry and regulatory compliance in accordance with federal, state, sponsor and institutional policies.

JobID: 179691

Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products for the Duke Cancer Institute’s Gastrointestinal Unit Clinical Research Program. The Oncology Clinical Research Unit oversees the conduct of research. The preferred candidate will have oncology or research experience, training, education.

JobID: 179294

Under the guidance of the Exec Director, Regulatory Affairs and the Director, Regulatory Strategy, the incumbent will provide regulatory guidance for Purdue development projects, across a broad range of therapeutic areas and in the disciplines of clinical and non-clinical development and manage preparation and compilation of regulatory dossiers (IND, NDA submissions). In addition, the incumbent will serve as the regulatory representative for Purdue on multiple assigned projects and interact with regulators/agencies. As such, the individual is responsible for preparation and management of clinical regulatory strategies and documents, and the execution of submissions for Purdue development and marketed products. (additional information including primary responsibilities, education, experience and skills provided on the Company’s website).

JobID: 80

UNC Lineberger Comprehensive Cancer Center Clinical Protocol Office

The Regulatory Manager is responsible for performance management of Clinical Protocol Office (CPO) Regulatory Staff. This supervisory role is comprised of staffing, work assignment, implementing the performance management program, supporting staff learning and development, leave management and schedules, and HR-related functions. This position is also responsible for the development and implementation of Regulatory Standard Operating Procedures. These responsibilities relate to the mission of the CPO by addressing the regulatory compliance, thereby ensuring the quality of research and institutional integrity. Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.

JobID: 20018256

Under the direction of the Director/Associate Director of Regulatory Affairs, this position involves providing guidance and assistance to Duke University investigators and study teams who need US Food and Drug Administration (FDA) oversight for their research projects. It encompasses working on FDA applications for a diverse portfolio of products with a focus on pre-market submissions for drugs, biologics, devices, and tobacco products. Projects can also entail meetings with FDA and helping to ensure compliant maintenance of effective FDA applications. Other duties will include training and assistance for investigational staff.

Requisition Number:  170915

Lead advertising & promotion activities. - Manage activities and communication are consistent with USPI and are in compliance with applicable laws, guidelines and Dompé policies; - Represent the Regulatory Affairs at PRC (Product Review Committee) and be responsible to revise, approve and submit materials for Dompé’s breakthrough therapy, the first-ever ophthalmic biologic product for patients suffering from a rare eye disease; - Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information - Improve the strategies for FDA promotional submission, working with both US and HQ team - Support senior director regulatory affairs for BLA maintenance activities such as submission of PAS, CBE-30, Annual Report, Distribution Report etc. - Maintain current awareness of evolving regulation and interpretation, working closely north America regulatory affairs leader.