Job Postings


Date Posted



  07/15/2020 Chiesi USA, Inc. Regulatory Affairs Specialist 1-3,
Labeling & Promotion

  Responsible for managing the labeling control process, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities; and for the regulatory review and submission of advertising and promotional materials for all Chiesi USA products. This position is also responsible for providing input to risk management activities.

  06/07/2020 Precision Biosciences Regulatory Writer

The Regulatory Writer will be a key member of the Regulatory Affairs team and interface with various Cell and Gene Therapy groups in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, journal editors, NIH, clinical trial sites/investigators). The Regulatory Writer will work with the Quality and Regulatory groups to ensure compliance with US, EU, and ICH requirements.

This is a primarily office-based position associated with the main headquarters in downtown Durham, NC. For the time being, this role will be able to function remotely in accordance with company safety guidelines throughout the duration of the pandemic but is subject to change as needed.  This position may require travel up to 10%

 04/30/2020 Dunn Regulatory Associates, LLC   Regulatory Operations Specialist 

Regulatory Operations Specialist needed with a minimum of 4 years of experience working in docuBridge, MS-Office, Adobe Acrobat, ISI Toolbox, data management, and have experience with various submission types, such as Pre-INDs, NDAs, BLAs and MAAs. Must be able to work independently and able to work with multiple clients to meet their regulatory publishing needs. Must reside in NC, VA or MD for this awesome full-time virtual opportunity. Contact Tanya Lane-Pringle @ [email protected]

 02/11/2020 UCB Regional Regulatory Science Lead

 •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. Education and Qualification: •Bachelor degree required •5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation.


JobID: 65233

 01/14/2020 Bavarian Nordic Sr Manager, Regulatory Affairs

  The Senior Manager, Regulatory Affairs (RA) is responsible for the regulatory management of projects through product development, registration processes and life-cycle management as well as coordination of multidisciplinary regulatory project teams. The Senior Manager RA will serve as the primary liaison with US regulatory authorities and is responsible for assisting with the development and implementation of regulatory strategy for BN’s products.

01/03/2020 Grifols R&D Regulatory Manager / Deputy Director, Regulatory Coordination
  Looking for the next Regulatory professional to join the GRIFOLS Family. If you have the following experience, please apply to the link listed. 10+ years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Ability to manage multiple complex projects and timelines in a matrix team environment. Ability to write and position comprehensive scientific information for use in regulatory submissions. Demonstrated interpersonal skills including strong negotiation skills. Experience in leading regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Strong leadership skills within a matrix driven organization.
01/03/2020 Grifols Regulatory Affairs Specialist / Senior- Spanish Speaking
  Fluency in Spanish is REQUIRED. Ideally should have regulatory experience. Flexible and adaptable to changing situations/projects within the company/industry; Basic knowledge of applicable laws and regulations. Ability to work under tight timelines to meet deadlines and business objectives. Superior skills with the use of MS-Office and ability to learn Regulatory specific software/electronic systems. Ability to work as part of the regulatory team to meet group objectives; Ability to clearly communicate verbally and in writing with external contacts that may include industry representatives, regulatory authorities at the federal, state, and local levels. Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.
12/14/2019 AskBio Vice President of Regulatory Affairs

The Vice President of Regulatory Affairs will be responsible for developing and leading all regulatory strategies and activities for AskBio including all regulatory submissions. This includes ensuring that all of AskBio regulatory goals are met, and in compliance with all current industry standards globally. This role will manage internal Regulatory staff, oversee third party Regulatory service providers, and will be a key member of the senior leadership team.

12/14/2019 AskBio Regulatory Affairs Director

The purpose of the Regulatory Affairs Director is to develop and lead the regulatory strategy and activities for the programs assigned, including all regulatory submissions. This includes ensuring that all AskBio regulatory goals are met, and in compliance with all current industry standards globally for the programs assigned.



United Imaging Healthcare

Sr. Regulatory Affairs Manager

Houston, TX

  United Imaging Healthcare is a leading global medical device developer and supplier with a diversified portfolio of advanced imaging equipment and healthcare IT solutions. We are building an innovative team with the mission of developing and supplying advanced technologies and improving patient care worldwide. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. The Regulatory Affairs Manager will be responsible for establishing best practices in the area of pre- and post-market regulations, submissions and new product development. This position will require short-term international travel and training in Shanghai, China.

  Provide proactive leadership of all RA issues. Lead company's product certification scheme. Drives establishment registration, device listing, and submits product reports via US-FDA Unified Registration and Listing System (FURLS). Supports the annual US-FDA sites registration and listing review and responds to RA information requests. Ensures marketing approval activities are in accordance with FDA requirements. Interprets FDA regulations and regulatory requirements to ensure product regulation compliance. Aware of and complies with the UIH Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position. Oversees complaint handling procedure. Provides company with support and guidance on medical device regulations. Maintains dashboards of activities and provides data for metrics.

JobID: 1002





Regulatory Affairs Specialist 1-3, Labeling & Promotion