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Regulatory Submission Publishing Specialist

Pleasanton, CA 94588

Posted: 09/08/2026 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12782 Pay Rate: $24.00 - $36.00 Remote Friendly: Remote

Job Description

Our client develops, manufactures and supplies a wide array of innovative medical diagnostic products, services, tests, platforms and technologies.

Overview:

We are seeking a Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team. The ideal candidate will manage and facilitate the preparation, submission, and publishing process of regulatory submissions intended for registration
purposes, primarily in the US or EU.


Key Responsibilities:
  • Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets.
  • Prepare submissions in accordance with external health authority guidelines, and internal standard practices.
  • Prepare and format documents according to publication and submission requirements.
  • Liaise with project leads, project teams, and regulatory bodies to gather
  • necessary documents and ensure smooth submission processes.
  • Maintain tracking systems to monitor the status and deadlines of all submissions.
  • Support the management of publication databases and repositories.
  • Collaborate with Regulatory Leads and Managers to ensure submission
  • deliverables meet requirements are fulfilled.

Job Requirements

Qualifications:
  • BA in Life Sciences, Regulatory Science, Quality, or related field.
  • Proven experience in preparing compliant regulatory submissions in the diagnostics or pharmaceutical sector.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency with industry-standard publishing and submission software and tools.
  •  Ability to manage multiple projects and meet deadlines in a fast-paced environment.
  • Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics.
  • Minimum years of experience: 5 years
     
Preferred:
  • Proficiency with industry standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals)
  • Previous experience in a diagnostics, pharmaceutical, or biotech company.

Meet Your Recruiter

Lexie Pierce
Senior Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Pleasanton, CA

Ready to embark on a fulfilling career journey in the vibrant region of Pleasanton, California? This picturesque city nestled in Alameda County offers a unique blend of suburban charm and exceptional growth opportunities for job seekers. Known for its charming downtown area with historic buildings, Pleasanton boasts a thriving arts scene with galleries like Firehouse Arts Center and Bankhead Theater. Indulge in the region's diverse cuisine, explore the scenic trails of Shadow Cliffs Regional Recreation Area, and catch a game of the Oakland Athletics at the nearby RingCentral Coliseum. Embrace the enchanting culture and endless possibilities that Pleasanton has to offer as you explore our curated job listings to find your perfect match. Let's kickstart your career journey in Pleasanton, CA today!