Senior Manager, Regulatory Affairs - ATMP
About the role
This vacancy has now expired. Please click here to view live vacancies.
Senior Manager, Regulatory Affairs ATMP
Location
The position may be remote based across the EU, or a mixture of office and remote based.
The Role
As a Senior Manager in Regulatory Affairs, you will provide expert knowledge on exciting area of ATMP within the Global Regulatory Affairs, CMC team which forms part of our Strategic Regulatory Services Group.
The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.
We are seeking individuals with experience in technical development, testing and manufacturing of advanced therapy medicinal products (ATMP). In particular, with cell and gene therapies experience in one of the following areas: analytical testing and characterization, control strategies, cell culture, vector production, process design/development, CAR-T cells development, stem cells development, viral or microbial gene therapies.
Responsibilities
Serve as a technical expert in development, testing and manufacturing of advanced therapy medicinal products (ATMP) and resource to ICON colleagues, and clients providing advice
Effectively manage the preparation of regulatory CMC submission documents
Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.
Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.
Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
Enthusiastically monitors for new regulatory requirements and shares key findings.
Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.
Education/Experience
Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.
Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.
Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. Europe, US, Japan, China).
Technical development, testing and manufacturing of advanced therapy medicinal products (ATMP)
Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.
Experience supporting business development activities and people management an asset.
Certification in regulatory affairs (RAC) or post-secondary institution beneficial.
Benefits Of Working In ICON
- Other than working with a great team of smart and energetic people, we also offer a competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
- We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career. We offer flexible and remote working opportunities.
- ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.
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
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/07/2025
Summary
Precision at the Outset: The Strategic Role of Site Selection and Activation in Clinical Trials The success of any clinical trial begins well before the first patient is enrolled. Behind every sit
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/04/2025
Summary
Cybersecurity in Clinical Data Management In clinical research, data is both a vital asset and a significant responsibility. As trials become increasingly digitised and decentralised, the protectio
.png)
Teaser label
IndustryContent type
BlogsPublish date
07/03/2025
Summary
Finding the Specialisation for You Clinical research is a dynamic, multidisciplinary field that brings together scientific innovation, operational rigour and patient-centric thinking. While many
Similar jobs at ICON
Salary
Location
Korea, South
Department
Clinical Trial Management
Location
South Korea
Seoul
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
Clinical Trial Manager - (Vaccines) - Home-based, South Korea As a (Clinical Trial Manager) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by heal
Reference
2025-120537
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
India, Chennai
Department
Full Service - Corporate Support
Location
Chennai
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Human Resources
Talent Acquisition
Job Type
Permanent
Description
We are currently seeking a Talent Acquisition Sourcing Specialist to join our diverse and dynamic team at ICON Plc. As a Talent Acquisition Sourcing Specialist at ICON, you will play a pivotal role in
Reference
JR131757
Expiry date
01/01/0001
Author
Rajkapoor KamaludeenAuthor
Rajkapoor KamaludeenSalary
Location
Bangalore
Department
Biometrics Roles
Location
Bangalore
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Biometrics Portfolio
Job Type
Permanent
Description
Senior Statistical Programmer Location: Bangalore/Chennai/Trivandrum-Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advanc
Reference
2025-120651
Expiry date
01/01/0001
Author
Himangshu Skekhar DasAuthor
Himangshu Skekhar DasSalary
Location
Korea, South
Department
Clinical Monitoring
Location
South Korea
Seoul
Remote Working
Office Based
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
CRA I/II - Home-based -South Korea As a (CRA I/II) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be supporti
Reference
2025-120607
Expiry date
01/01/0001
Author
Sonia OhAuthor
Sonia OhSalary
Location
Brazil
Department
Clinical Trial Management
Location
Brazil
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
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
2025-120505
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Mexico, Mexico City
Department
Full Service - Corporate Support
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
HR Advisor
Job Type
Permanent
Description
Hybrid Role: 3 days in the office / 2 days remote (home office)Location: Insurgentes Sur, Mexico CityWe are currently seeking an HR Advisor to join our diverse and dynamic team supporting our LATAM em
Reference
JR132381
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela Guerrero