JUMP TO CONTENT

Director, Regulatory Operations

  1. Sofia, Dublin, Limerick, Warsaw, Johannesburg, Barcelona, Madrid, Reading, Swansea
JR124836
  1. ICON Full Service & Corporate Support
  2. Drug / Device Regulatory Affairs
  3. Hybrid: Office/Remote

About the role

Director, Regulatory Operations

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.

We are currently seeking a Director, Regulatory Operations to join our diverse and dynamic team. As a Director, Regulatory Operations at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing

  • Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.

  • Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.

  • Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.

  • Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.

  • Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.

Your profile

  • Bachelor's degree in a scientific or related field; advanced degree preferred.

  • 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.

  • Strong understanding of global regulatory requirements and guidelines.

  • Proven track record of successful regulatory submissions and approvals.

  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.

  • Proven leadership experience

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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

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
Salary: Let’s talk about it.

Teaser label

Career Progression

Content type

Blogs

Publish date

12/21/2022

Summary

Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune

Teaser label

Things to consider heading into 2023 if you're thinking about moving jobs.

Read more
Jamie Kempski

by

Jamie Kempski

Jamie Kempski

by

Jamie Kempski

4 life sciences jobs that are taking off

Teaser label

Inside ICON

Content type

Blogs

Publish date

11/24/2022

Summary

Life sciences are undeniably an exciting area to start and pursue a career in. In fact, the global life sciences space is predicted to be worth a massive $2 trillion in gross value by 2023. Contra

Teaser label

Life sciences are undeniably an exciting area to start and pursue a career in.

Read more
View all

Similar jobs at ICON

Regulatory Affairs Specialist

Salary

Location

Philippines, Manila

Department

Full Service - Regulatory

Location

Manila

Remote Working

Hybrid: Office/Remote

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

JR124855

Expiry date

01/01/0001

Leslie Garcia

Author

Leslie Garcia
Read more Shortlist Save this role
Regulatory Operations Associate

Salary

Location

Bulgaria, Sofia

Location

Sofia

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

Description

Job DescriptionProvide support for submissions and other documents by performing necessary tasks including assembly, dispatch and coordinating resources for submissions to CTIS.Maintain submission com

Reference

JR124028

Expiry date

01/01/0001

Clodagh Finnegan Read more Shortlist Save this role
Manager, Regulatory Operations

Salary

Location

Poland, Warsaw

Location

Sofia

Warsaw

Remote Working

Hybrid: Office/Remote

Business Area

ICON Full Service & Corporate Support

Job Categories

Drug / Device Regulatory Affairs

Job Type

Permanent

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

JR122269

Expiry date

01/01/0001

Clodagh Finnegan Read more Shortlist Save this role

Browse popular job categories below or search all jobs above