JUMP TO CONTENT

Senior Global Regulatory Scientist FSA

  1. Sofia, Warsaw, Johannesburg
JR128913
  1. ICON Full Service & Corporate Support
  2. Regulatory Affairs
  3. Office or Home

About the role

Senior Global Regulatory Scientist - Home- or Office-based - Bulgaria, Poland or South Africa

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Responsibilities:

• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles.
• Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable.
• Regulatory function team lead overseeing the assigned clinical trial Regulatory project team.
• Point of contact for clients for clinical trial Regulatory deliverables.
• Preparation of clinical trial Regulatory plan in accordance with project specifications.
•Preparation/creation/adaptation/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in addition to study requirements.
• Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents.
• Performing Quality Control review of clinical trial Regulatory deliverables in accordance with applicable process.
• Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team.
• Coordination of clinical trial label review/approval according to project specifications.
• Managing Regulatory study budget, proactively identifying out of scope activities and supporting budget recognition.
• Supporting the maintenance of accurate, up to date Country and Regulatory Intelligence.
• May work with Regulatory team members to provide Regulatory consulting services.
• May participate in business or organizational development activities.
• May mentor junior team members.

Job Requirements:

• BSc degree in a scientific field.

• 3-6 years’ relevant global regulatory experience in clinical trials for pharmaceuticals.

• Good communications and client-facing skills.

• Adaptive personality with an agile mindset.
• Fluent English.

#LI-Remote

#LI-Onsite

#LI-Hybrid

#LI-MK2

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 maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

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, color, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply

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
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
Vaccination vial
The Role of Regulatory Affairs in Clinical Research

Teaser label

Industry

Content type

Blogs

Publish date

01/18/2024

Summary

Introduction to Regulatory Affairs in Clinical Research Regulatory affairs play a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices. In the

Teaser label

Explore the pivotal role of regulatory affairs in clinical research with our insightful blog.

Read more
View all

Similar jobs at ICON

Senior Manager, CMC strategy - Homebased in UK, Poland, Spain or Germany

Salary

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

Senior Manager, Regulatory Strategy (CMC strategy) - Homebased in UK, Poland, Spain or GermanyAs a Senior Manager, Regulatory Strategy (CMC strategy) you will be joining the world’s largest & most com

Reference

2025-121717

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior Regulatory Affairs Specialist (CMC author) - 1-year Fixed term contract

Salary

Location

London, Poland, Spain, Germany

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Germany

Poland

Spain

London

Remote Working

Home-Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

Senior Regulatory Affairs Specialist (CMC author) - Homebased in UK, Poland, Spain or Germany (fixed term contract 1 year) As a Senior Regulatory Affairs Specialist (CMC) you will be joining the world

Reference

2025-121648

Expiry date

01/01/0001

Patrick Hale

Author

Patrick Hale
Read more Shortlist Save this role
Senior TMF Specialist

Salary

Location

India, Chennai

Department

Clinical Trial Management

Location

Chennai

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 Senior TMF Specialist to join our diverse and dynamic team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clin

Reference

JR132671

Expiry date

01/01/0001

Amrutha Saidala Read more Shortlist Save this role
Clinical Trial Documentation Specialist (Poland, Warsaw)

Salary

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) to join our diverse and dynamic team. As the Specialist at ICON, you will play a vital role in becoming familiar wit

Reference

JR129275

Expiry date

01/01/0001

Jacek Jaworski Read more Shortlist Save this role
Regulatory Project Manager - East Coast

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us

Reference

2025-121707

Expiry date

01/01/0001

Kala Murphy

Author

Kala Murphy
Kala Murphy

Author

Kala Murphy
Read more Shortlist Save this role
Study Start Up Associate II

Salary

Location

Mexico City

Department

Regulatory, Drug Safety/ Quality Assurance & Other roles

Location

Mexico City

Remote Working

Office Based

Business Area

ICON Strategic Solutions

Job Categories

Regulatory Affairs

Job Type

Permanent

Description

The  Study Start-Up Associate performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accord

Reference

2025-121424

Expiry date

01/01/0001

Rita Villavicencio Read more Shortlist Save this role
View Jobs

Browse popular job categories below or search all jobs above