Job Postings

 

Date Posted

Company

Position

  04/26/2021 Precision BioSciences Senior Associate, Regulatory Affairs

  The Senior Associate, Regulatory Affairs plays a critical role in organizing, training, and leading regulatory associate staff in handling all day-to-day regulatory operations activities for the company. The Senior Associate, Regulatory Affairs also leads or supports complex strategic regulatory activities, coordinating across functions as needed to assemble or support assembly of information from relevant disciplines to produce complete, high-quality regulatory submissions. Finally, the Senior Associate, Regulatory Affairs serves as an important consultative resource for junior Regulatory Affairs staff as well as staff in other segments of the company.

 
  04/13/2021 Merz Director, Regulatory Affairs

  The Director, Regulatory Affairs leads a team of regulatory professionals and is accountable for the regulatory deliverables under their supervision.  Position provides guidance on the development and execution of regulatory strategies for new products and lifecycle management of existing products. Position supports Marketing and Legal teams on regulatory issues with potential business impact.

JobID: 001

 
  04/13/2021 Merz Associate Director of Regulatory Affairs, AX Division

Merz’s Associate Director of Regulatory Affairs, Ax Division must have a proven track record of achieving FDA regulatory approvals/clearances along with implementing the tenets of regulatory requirements within the business.  This regulatory individual has responsibility for achieving license approvals in the growing injectables portfolio of products. He/she will lead the Ax R&D regulatory space in developing global regulatory strategies and submissions, and by sharing his/her regulatory knowledge and expertise with other functional leaders in support of regulatory lifecycle management activities (pre- and post-market.).

JobID: 002

 
  04/13/2021 Merz Manager, Regulatory Affairs

The Manager, Regulatory Affairs develops and executes regulatory strategies for new products and lifecycle management of existing products. Acts as primary contact for regulatory on cross functional product development and post-marketing teams and leads submission activities throughout product development and lifecycle.

JobID: 003

 
  04/12/2021 Chiesi USA, Inc. Intern, US Regulatory Affairs R&D - Pipeline
  The Chiesi – US Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and/or biologics. The focus will primarily be on-the-job training experience, with additional education and training including FDA and industry-sponsored lectures.
 
  04/12/2021 Chiesi USA, Inc. Intern, Regulatory Affairs, US Global Rare Diseases

  The Chiesi - Regulatory Affairs internship will be an immersive experience that will include exposure to several regulatory projects directly related to the development of drugs and biologics. Education and training will include some FDA, EMA, and Industry Sponsored lectures but the focus will be a mainly on-the-job training experience.

 

 
  03/29/2021 MMS Senior Regulatory Operations Specialist

MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. The Senior Regulatory Operations Specialist practices excellent internal and external customer service and in the project lead role:

  • Prepares and compiles documents for submission to regulatory health authorities
  • Publishes regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems
  • Performs quality control checks to regulatory submissions to ensure compliance with ICH and company defined standards
  • Maintains regulatory submission tracking log and imports archival submissions into company document management system
  • Creates, formats, and reviews documents and references to meet style guide and submission ready requirements

See the link to the position for more details!

JobID: 001

 
  03/29/2021 UNC Lineberger Comprehensive Cancer Center Assistant Director of Regulatory Affairs and Compliance

  The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Oncology Clinical Protocol Office (CPO) is primarily responsible for organizing, managing, conducting, and supporting these trials. Working with the CPO Medical Director and the LCCC Associate Directors, the Assistant Director of Regulatory Affairs and Compliance oversees CPO regulatory operations, and reporting requirements for oncology clinical trials associated with the Cancer Center. The position also oversees the CPO training program to ensure the highest level of quality in the clinical research conducted at the Lineberger Comprehensive Cancer Center.

JobID: 20037788

 
  03/29/2021 UNC Lineberger Comprehensive Cancer Center Regulatory Associate

  The Regulatory Associate is responsible for regulatory compliance of an assigned disease group(s) which includes providing regulatory guidance and training to investigators and CPO staff; preparing and submitting required regulatory documents and responses to regulatory bodies (e.g., Institutional Review Boards (IRB)); and creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the UNC/LCCC CPO mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

JobID: 20038061, 20038062

 
  03/29/2021 UNC Lineberger Comprehensive Cancer Center Regulatory Assistant

  The primary purpose of this position is to provide para-professional support within the Regulatory staff of the Lineberger Protocol Office. The Regulatory Assistant gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board (IRB) and research sponsors. This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. Regulatory Assistants participate in the collection, compilation and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. Regulatory Assistants are expected to use considerable judgment and research skills in performing their work assignments. Work may include the training and supervision of staff, students and others.

JobID: 20005702, 20038059, 20038060

 
  03/24/2021 UNC Lineberger Comprehensive Cancer Center Clinical Protocol Development Associate

  The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Oncology Clinical Protocol Office (CPO) is primarily responsible for organizing, managing, conducting, and supporting these trials. This position will collaborate in writing, editing, producing and reviewing oncology clinical trials LOIs (letters of intent) and protocols. Priority of work is primarily self-directed with input and guidance from senior MD faculty in the clinical research program, immediate supervisor and the Senior Clinical Protocol Development Associate.

JobID: 20001357

 
  03/10/2021 Lindsey Regulatory Affairs Consulting Regulatory Affairs Specialist - Medical Devices

 The Regulatory Affairs Specialist applies their knowledge to the delivery of regulatory and quality solutions to enable client success. The Regulatory Affairs Specialist delivers quality service and executes the defined consulting scope of work with minimal oversight by experienced consultants. This role has the day to day responsibility for leading client projects to support product development, submissions, and post marketing activities.

JobID: 004

 
  03/09/2021 Shattuck Labs Director of Regulatory Affairs

  The Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional regulatory requirements, and company policies. This role will ensure effective communication with business partners and regulatory authorities worldwide, including planning and leading meetings with regulatory authorities. This position will oversee and provide direct input to global regulatory strategy and submissions for therapeutic biological projects in both early and late development, including submission of high-quality INDs/CTAs, BLAs/MAAs, meeting packages, amendments, and required elements such as safety reports, annual reports. The person fulfilling this role will work as part of a growing Regulatory Team in a dynamic company.

 
  03/08/2021 GeneCoda Regulatory Affairs Client Liaison

  Our client, a leading provider of scientific and regulatory consulting services to Pharmaceutical clients, is a division of a global quality assurance services firm that provides customized qualification solutions to varied industries. Our client’s emphasis is in preparing IND filings for small to mid-sized biotech and pharmaceutical companies, including electronic submissions. As such, our client’s work environment will appeal to professionals who enjoy varied client experiences including work in exciting new science like CRISPR and gene editing. Our client seeks a Regulatory Affairs professional with a technical background in submissions (e.g. IND, NDA) that has a prior background in or affinity for client interaction and business development.

JobID: 1089