Manager, Regulatory CMC (lifecycle management)
- Any EMEA Location
- ICON Strategic Solutions
- Regulatory Affairs
- Home-Based
TA Business Partner
- Icon Strategic Solutions
About the role
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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
.jpg)
Teaser label
Inside ICONContent type
BlogsPublish 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
.png)
Teaser label
Our PeopleContent type
BlogsPublish 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
.jpg)
Teaser label
Career ProgressionContent type
BlogsPublish 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
Similar jobs at ICON
Salary
Location
Brazil
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Brazil
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2025-119840
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
UK, Reading
Location
Reading
Remote Working
Home or Office
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
Author
Caroline LockAuthor
Caroline LockSalary
Location
Poland, Warsaw
Department
Full Service - Corporate Support
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Documentation Specialist (TMF Specialist I) to join our diverse and dynamic team. As the Specialist at ICON, you will play a vital role in becoming familiar w
Reference
JR129272
Expiry date
01/01/0001
Author
Jacek JaworskiAuthor
Jacek JaworskiSalary
Location
Poland, Warsaw
Department
Clinical Trial Management
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Regulatory Document Management
Job Type
Permanent
Description
We are currently seeking a TMF Specialist I to join our diverse and dynamic team. As a TMF Specialist I at ICON, you will play a vital role in becoming familiar with Trial Master File (TMF) documentat
Reference
JR131984
Expiry date
01/01/0001
Author
Magda KozuszekAuthor
Magda KozuszekSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Mexico City
Remote Working
Home or Office
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
Author
Ana LuciaAuthor
Ana LuciaSalary
Location
Europe
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Any EMEA Location
Remote Working
Home-Based
Area of interest
Europe ICON Full Service & Corporate Support Talent Acquisition
Business Area
ICON Strategic Solutions
Job Categories
Regulatory Affairs
Job Type
Permanent
Description
Regional CTA submission manager (EU CTR) - Homebased in UK or Europe An exciting new role with ICON within our regulatory team working on high profile Pharma projects with a client with which ICON sha
Reference
2025-120090
Expiry date
01/01/0001
Author
Patrick HaleAuthor
Patrick Hale