Senior Regulatory Affairs Specialist
- Beijing
- ICON Full Service & Corporate Support
- Drug / Device Regulatory Affairs
- Hybrid: Office/Remote
TA Business Partner
- Full Service Division
About the role
Senior RA - China
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 Senior Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Regulatory Affairs Specialist at ICON, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of inNvative treatments and therapies.
What you will be doing- Leading the preparation, submission, and maintenance of regulatory documents for clinical trials.
- Providing expertise and guidance on regulatory requirements and standards to internal teams.
- Interfacing with regulatory agencies to address inquiries, submissions, and approvals.
- Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks.
- Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
- Strong kNwledge of global regulatory requirements and guidelines for clinical trials.
- Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
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
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 Read more
Day in the life
Similar jobs at ICON
Salary
Location
UK, Reading
Location
Sofia
Dublin
Limerick
Warsaw
Johannesburg
Barcelona
Madrid
Reading
Swansea
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 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 c
Reference
JR124836
Expiry date
01/01/0001
Author
Hajni HowardAuthor
Hajni HowardSalary
Location
Poland, Warsaw
Location
Warsaw
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
Author
Clodagh FinneganAuthor
Clodagh FinneganSalary
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
Author
Clodagh FinneganAuthor
Clodagh Finnegan