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Regulatory Affairs guide

Every Regulatory Affairs program at Regulated Science Institute in one place: who each program is for, what you will learn and how long it takes.

6 programs
84 hours of study
PDF to keep

How to use this guide

Start with the program closest to your current role, then add the ones your next role asks for. Each entry below lists who the program is written for and the skills you leave with, so you can compare them side by side. Every program ends with a digital certificate of completion you can add to LinkedIn.

1

US Drug and Biologics Regulatory Pathways Professional Certificate

About 16 hours · online, self-paced · certificate

Who it is for

Scientists, clinicians, and project managers moving into regulatory affairs roles at drug and biologics sponsors or CROs.

What you will learn

Map a product's path from pre-IND through approval and lifecycle management
Outline the contents of an IND and an NDA/BLA in CTD format
Choose and justify an appropriate expedited program for a development candidate
Prepare a well-structured FDA meeting request and briefing package outline
Explain PDUFA review clocks and key post-approval obligations

2

US Medical Device Premarket Submissions Professional Certificate

About 14 hours · online, self-paced · certificate

Who it is for

Engineers, quality staff, and life-science graduates who want to prepare or support 510(k), De Novo, and PMA submissions.

What you will learn

Classify a device and identify the correct premarket pathway
Select and defend a predicate device
Assemble the major sections of an eSTAR 510(k)
Plan a Pre-Submission to resolve open questions with FDA
Decide when a device modification requires a new submission

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3

EU MDR and IVDR Compliance Certificate Program

About 16 hours · online, self-paced · certificate

Who it is for

Regulatory, quality, and clinical professionals at device and diagnostics companies selling into the European Union.

What you will learn

Classify devices and IVDs under the EU regulations
Build a technical documentation table of contents mapped to Annex II and III
Draft a GSPR compliance checklist
Explain clinical evaluation and PMCF obligations
Set up a compliant PMS and vigilance process

4

CMC Regulatory Affairs Professional Certificate

About 16 hours · online, self-paced · certificate

Who it is for

Chemists, process engineers, and QA/QC staff who want to move into CMC regulatory roles.

What you will learn

Outline Module 3 content for a small molecule and a biologic
Link CQAs and process parameters to a control strategy
Classify a manufacturing change and choose the correct US filing category
Use ICH Q12 tools to reduce post-approval filing burden
Plan a comparability exercise for a biologics process change

5

Regulatory Operations and eCTD Submissions Certificate Program

About 12 hours · online, self-paced · certificate

Who it is for

Administrative, publishing, and documentation professionals seeking entry-level regulatory operations jobs.

What you will learn

Place any document correctly within the CTD structure
Plan an eCTD sequence and lifecycle operations
Prevent the most common technical rejection errors
Explain what changes with eCTD v4.0
Describe how RIM systems support submission planning

6

Drug Supply Chain Security and Traceability Certificate Program

About 10 hours · online, self-paced · certificate

Who it is for

Supply chain, distribution, pharmacy operations, and trade compliance staff at manufacturers, wholesalers, 3PLs, and dispensers.

What you will learn

Explain each trading partner's DSCSA obligations
Read and validate a product identifier and EPCIS event
Run a suspect product investigation to closure
Track exemption deadlines that apply to a given organization
Build a DSCSA compliance checklist and SOP set

See the Regulatory Affairs programs