JUMP TO CONTENT

Manager, Regulatory CMC (lifecycle management)

  1. Any EMEA Location
2025-120133
  1. ICON Strategic Solutions
  2. Regulatory Affairs
  3. Home-Based

About the role

This vacancy has now expired. Please click here to view live vacancies.

As a Manager, Regulatory CMC (lifecycle management) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 

We are seeking 2 roles within our Regulatory CMC team

  • CMC Life Cycle Management experience for Drug substance and Drug product is essential for this role.
  • The position will involve planning and roll out
  • strategic inputs for CMO addition
  • VRIM expertise
  • Change control assessment and regulatory planning, good to have facility knowledge.
  • One will support Rare Endocrine portfolio of established products and the other Haemofilia established portfolio

What you will be doing:

  • Plan, execute and manage regulatory submissions for assigned compounds or projects with appropriate supervision from RA CMC Management.
  • Define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.
  • Successfully communicate and negotiate with international subsidiaries and Health Authorities. Prepare meetings with Health Authorities and represent Regulatory Affairs CMC as necessary.
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
  • Collaborate with manufacturing sites to successfully compile required documentation.
  • Interact with other internal and external colleagues, as well as with other functional areas and Alliance Partners.
  • Evaluate change proposals for regulatory impact and filing requirements.
  • Manage responses to letters of objections from Health Authorities for marketing authorization applications, product variations and renewals of international medicinal products.

You are:

Accurate, timeline-driven and passionate about science.

Here at Icon we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

  • Previous experience working in regulatory CMC and compiling Module 3 documentation in a pharmaceutical environment
  • A relevant educational background (preferably as a Chemist, Pharmacist or Biologist)
  • The ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives, and assess the impact of change requests against regulatory guidelines
  • Problem-solving ability, flexibility and team player
  • Fluency in written and spoken English

 

#LI-PH1


What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others



Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

List #1

Day in the life

A picture of chemists on a superimposed periodic table
5 reasons why you should consider a career in Clinical Research

Teaser label

Inside ICON

Content type

Blogs

Publish date

01/17/2025

Summary

Five Reasons Why You Should Work at a Contract Research Organization Contract research organisations (CROs) play a pivotal role in advancing medical science, offering career opportunities that are

Teaser label

If you’re seeking a rewarding and fulfilling work environment, a career at a CRO might be the perfect fit.

Read more
5 different images of lab technicians
How to become a Clinical Research Associate (CRA)

Teaser label

Our People

Content type

Blogs

Publish date

11/13/2024

Summary

How to Become a Clinical Research Associate:   A Step-by-Step Guide The clinical research industry is projected to reach $52.0 billion by 2026, growing at an impressive rate of 5.6% annually. This

Teaser label

Explore the step-by-step guide on how to become a Clinical Research Associate (CRA).

Read more
Man with headphones on looking at a laptop
Tips to make a lasting impression in a video interview

Teaser label

Career Progression

Content type

Blogs

Publish date

05/10/2024

Summary

Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv

Teaser label

Ace your virtual job interview with these proven video interview tips.

Read more
View all

Similar jobs at ICON

Regulatory Scientist

Salary

Location

UK, Reading

Location

Reading

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

As a Senior Regulatory Scientist you will be working mostly with the ICON Clinical Trial Units in the Netherlands and Hungary. You will be responsible for completion of country Clinical Trial Regulato

Reference

JR130969

Expiry date

01/01/0001

Caroline Lock

Author

Caroline Lock
Read more Shortlist Save this role
Senior Regulatory Operations Associate - Fixed Term Position

Salary

Location

Brazil, Sao Paulo

Location

Sao Paulo

Mexico City

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Temporary Employee

Description

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I

Reference

JR131937

Expiry date

01/01/0001

Ana Lucia

Author

Ana Lucia
Ana Lucia

Author

Ana Lucia
Read more Shortlist Save this role
Senior Global Regulatory Scientist

Salary

Location

Poland, Warsaw

Location

Sofia

Warsaw

Johannesburg

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Job Responsibilities:• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with soun

Reference

JR129985

Expiry date

01/01/0001

Maya Katsarska Read more Shortlist Save this role
Senior Manager, Regulatory Affairs

Salary

Location

Japan, Tokyo

Location

Osaka

Tokyo

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analy

Reference

JR127715

Expiry date

01/01/0001

Haruna Yamabayashi Read more Shortlist Save this role
Regulatory Affairs Specialist

Salary

Location

Japan, Tokyo

Location

Osaka

Tokyo

Remote Working

Office or Home

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clini

Reference

JR129971

Expiry date

01/01/0001

Haruna Yamabayashi Read more Shortlist Save this role
Director, Regulatory Affairs

Salary

Location

United States

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

United States

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

As a Director, Regulatory Affairs, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Reference

2025-120930

Expiry date

01/01/0001

Jonathan Holmes Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above