Regulated Science Institute
Regulatory Operations and eCTD Submissions Certificate Program cover

Regulatory Affairs$395Certificate

Regulatory Operations and eCTD Submissions Certificate Program

About 12 hours

Written for administrative, publishing, and documentation professionals seeking entry-level regulatory operations jobs.

$395 per person. Online and self-paced.

Regulatory affairs professional in a blazer holding a laptop

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

How it works

  1. Online and self-paced

    The lessons are online, with an audio version of each, so you can study at your own pace.

  2. Earn a certificate

    Finish every lesson to receive a certificate with a unique ID that anyone can verify.

  3. Enroll online

    Pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.

Earn a verified certificateFinish every lesson to receive a certificate with a unique ID that employers can check. Add it to LinkedIn in one click.See a sample

Questions about this program

How long does Regulatory Operations and eCTD Submissions Certificate Program take?

About 12 hours of study. It is online and self-paced, so you can spread it over the weeks that suit you.

Who is this program for?

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

Do I get a certificate?

Yes. When you finish every lesson you receive a digital certificate of completion with a unique ID that anyone can check at regulatedscience.org/verify/. You can add it to your LinkedIn profile.

Is there an audio version?

Yes. Every lesson has an audio version, so you can listen on the go.

How much does it cost?

$395 per person. Email support@regulatedscience.org for team pricing.

How do I enroll?

Select "Enroll" on this page and pay securely by card, Apple Pay or Google Pay. Your account is ready as soon as the payment goes through.

Can my team take it together?

Yes. We offer group enrollment for companies, CROs and consultancies. Email support@regulatedscience.org with the programs and the size of your team.

Not ready to enroll?

Leave your email and we will send you the syllabus and news about this program. You can ask us to remove it at any time.

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Program
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Regulatory Affairs 5
Clinical Operations 4
Quality & Compliance 5
Drug Safety & Pharmacovigilance 2
Market Access & HEOR 2
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