Regulatory Affairs Specialist (Remote - US)

mmsholdingsinc; Deutschland; Remote; EUR 60,000 - 90,000; Full time

Job summary

MMS Holdings, Inc. in Germany seeks a Regulatory Affairs/Publishing specialist to manage document submissions and ensure compliance with ICH guidelines across regulatory operations.

You will coordinate with CROs, local authorities and vendors, prepare submission packages, perform quality checks, maintain submission trackers, and support eCTD publishing in line with client standards.

Experience with ICH eCTD, FDA/Japanese portals, and regulatory document control is preferred.

Qualifications

• Bachelor's degree in science or related field; equivalent experience accepted.
• Minimum 3 years in Regulatory Affairs/Publishing or similar field.
• Familiarity with ICH guidelines and ISO standards.
• Proficiency with MS Office and Adobe Acrobat.
• Experience with eCTD publishing and regulatory submissions.

Responsibilities

• Publish regulatory documents and submissions according to ICH eCTD standards.
• Maintain regulatory tracking and archiving of submissions.
• Prepare and compile documents for regulatory health authorities.
• Perform quality control checks on documents and submissions.
• Coordinate with CROs, local authorities and vendors on submissions.
• Support project plans and timelines for submission readiness.

Skills

Regulatory knowledge

ICH guidelines

Document management

Regulatory operations

Project coordination

Education

Bachelor's degree in science or related field

Tools

MS Office

Adobe Acrobat

eCTD publishing tool

ISI ToolBox

SAS Viewer

WebTrader/ex-US portals

Job description

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.