Pharmaceutical Regulatory Affairs: Life After Life Science, #2

By CF Harrison

Regulatory affairs.

If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers.

But...what exactly is regulatory affairs?
What would I be doing?
What sort of skills do I need?
What do I need to know before I start?

This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem.

Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.

• Language: English
• Publisher: HSA
• Release date: Aug 19, 2016
• ISBN: 9798223395898

Book preview

So what exactly is regulatory affairs?

Regulatory affairs. If you’re moving out of life science and are currently looking for a job in the biotech or health sectors, you’ve probably seen a thousand advertisements looking for regulatory affairs managers. Regulatory affairs is a vast field, a growing field, and an excellent goal for people moving out of the lab. But what exactly does this mean? What on earth is regulatory affairs, and what would I be doing?

This book will provide an introduction to the world of regulatory affairs for those who are interested in starting or who have just started. We’ll cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you’ll need to have; and much more. Lost in a sea of acronyms? We’ve got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem.

Whether you’ve just started the job or are preparing for your first interview, this book will give you the foundational knowledge you need to succeed.

Table of Contents

So what exactly is regulatory affairs?

Table of Contents

The Job: What will I actually be doing?

Communicating

Managing

Organising

Interacting with Health Authorities

Writing dossier modules

Working with source documents

Providing regulatory advice

The Ability: What skills do you need?

Communication (verbal and written)

Time management and Organisation

Pragmatism and Prioritisation

Problem Solving and Analytical thinking

Scientific background

Regulatory Affairs experience

High-level English writing skills

Skills you don’t need: Lab skills

The Field: What does regulatory affairs include?

Chemistry, Manufacturing and Controls

Preclinical and Clinical Studies

Labelling

Medical Devices

Generics

Biosimilars

The Dossier: What is it, and how do I write it?

The Common Technical Document (CTD)

The eCTD

The Process: Regulatory affairs and the development lifecycle

Discovery and preclinical development

Clinical studies

Pre-Submission and Dossier Writing

Health authority meetings and interactions

Submission, Requests for Information, Marketing Approval

Submission to EMA

Submission to the FDA

Requests for Information and Deficiency Letters

Pre-approval inspections

Approval

Lifecycle Management

Annual Reports

Change evaluation

Post-approval changes and the FDA

Post approval in the European Union: EMA

The Gatekeepers: Health Authorities

United States of America (FDA)

European Union (EMA)

Canada (Health Canada)

Japan (MHLW & PMDA)

Australia (TGA)

Secondary Health Authorities

The Certificate of Pharmaceutical Product, or CPP

Appendix 1: Drug regulation – a short history

Appendix 2: CTD Subsections

Module 1

Module 2

Module 3

Module 4

Module 5

Appendix 3: Acronyms and Abbreviations

About the author

The Job: What will I actually be doing?

This question comes up all the time, and it’s basically impossible to answer. The job is variable, exciting, and challenging. Every day will be slightly different – most days your careful plan will be thrown out the window within the first hour. While I can’t tell you a typical ‘day in the life’ of a regulatory manager, these are the things that you will do most often...

Communicating

At its most basic level, regulatory affairs managers act as traders in information. They stand at the midpoint between a vast variety of departments, experts and regulators – their job is to keep information flowing between each and every one of them. Emails, reports, meetings, phone calls, the regulatory affairs job involves keeping people up to date and in the loop. Communication lies at the heart of regulatory affairs, so expect to do a lot of it.

Managing

The title is usually given as Regulatory Affairs Manager, and so it’s fairly clear that there is management involved. But it’s not ‘management’ in the sense of having people reporting to you and doing the tasks you assign them (well, not until you get a bit further in at least). Instead it’s managing people without actually having any formal authority over them – what’s often known as matrix management. You can’t give orders, you’ll have to persuade, wheedle, nag, bargain, compromise and trade your way to your goals. This is not to say that people won’t want to help you, everyone rises and falls together after all, but each expert you approach will have many demands for their time. Why should they help you? You need to be persuasive, and this is why interpersonal skills are one of the main talents HR looks for when hiring.

Organising

Are you organised? You’d better be – most regulatory managers will be juggling multiple projects at any one time, plus various meetings and whatever emergency has come up this time. Being able to keep track of these requirements is a must. You’ll need to be able to plan both in the short term (today’s chaos) and the long term (what is our 4 year development plan?). Here the typical scientific background, with its multitasking of experiments, writing,