Regulatory Operations Specialist (Remote - US)

MMS Holdings Inc; Austin (TX); Remote; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

MMS Holdings Inc is an award-winning, data-focused clinical research organization (CRO) known for a Great Place to Work certification and a collaborative culture. We support pharmaceutical, biotech, and medical device industries with rigorous data and regulatory submission solutions worldwide.

We are seeking a Regulatory Operations/Publishing professional to manage regulatory document publishing, tracking, and submissions in alignment with ICH eCTD standards, working closely with

Qualifikationen

• Minimum 3 years in Regulatory Affairs or related field.
• College graduate in scientific/medical discipline, masters preferred.
• Proficiency with MS Office and Adobe Acrobat.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Experience with eCTD publishing and regulatory submissions.
• Strong communication and problem-solving skills.
• Understanding of CROs and regulatory data terminology.

Aufgaben

• Publish regulatory documents to eCTD format.
• Prepare and compile documents for regulatory submissions.
• Maintain submission project plans and track components.
• Perform quality control checks on documents and submissions.
• Coordinate with CROs, Authorized Agents, and vendors.
• Manage multiple regulatory submissions and timelines.
• Gains understanding of eCTD structure.

Kenntnisse

Regulatory knowledge

Publishing

Documentation management

Quality control

Problem-solving

Communication skills

Team collaboration

ISO 9001 knowledge

GxP awareness

Ausbildung

College graduate in scientific/medical discipline

Masters preferred

Tools

MS Office

Adobe Acrobat Professional

ISI ToolBox

eCTD publishing tool

SAS Viewer

eCTD Viewer

WebTrader/ex-US portals

Jobbeschreibung

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

Job Specific Skills

• Gains understanding of applicable regulations and ICH and health authority guidance as they pertain to document management and Regulatory Operations.
• Maintaining regulatory tracking and archiving of submissions in document management systems.
• Publishing regulatory documents and submissions according to ICH eCTD format, submission ready standards and client style guides.
• Preparing and compiling documents for submission to regulatory health authorities.
• Perform quality control checks to documents and regulatory submissions to ensure compliance with ICH and MMS and clientstandards.
• Gains understanding of the eCTD structure and the structure and content of clinical study reports.
• Gains understanding of simple coordination with clinical CROs, local Authorized Agents and third-party vendors on regulatory submissions.
• With support from Sr ROS or LM: Maintain submission project plan and track components; Manage project risks and timeline; Manage multiple projects simultaneously.

Job Requirements

• College graduate in scientific, medical, clinical discipline or related field, or years of relevant experience, masters preferred.
• Minimum of 3 years’ experience in Regulatory Affairs, Regulatory Operations, Publishing or similar field required.
• Gains understanding of MS Office and Adobe Acrobat Professional, ISI ToolBox, eCTD publishing tool, SAS Viewer, eCTD Viewer and WebTrader/ex-US portals.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Word Formatting, Adobe and other MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Understanding of CROs and scientific & clinical data/terminology, & the drug development process.