Regional Regulatory Affairs Manager
- Taiwan
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
Job Title: Regional Regulatory Affairs Manager
Working model: Home based
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a "Regional Regulatory Affairs Manager" to work closely with our client, a leading pharmaceutical company.
Overview
Provides an interface to top 10 pharma Regulatory and Global Product Development (GPD) partners within designated Pfizer Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory CTA and Central Ethics submissions to regional partners and selected Health Authorities.
The Regional/Global CTA Submission Manager (CTA-SM) is accountable for working with contributing Top 10 pharma business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
Key responsibilities
- Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaise with pharma Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
Required experience and qualifications
- B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable);equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA and Central Ethics processes globally
- It would be great to have APAC Clinical Regulatory experience.
- Good command of English; Native speaker of Chinese
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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
#LI-ST1
#LI-Remote
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Who we are
Similar jobs at ICON
Salary
Location
US, Blue Bell (ICON)
Location
Raleigh
Blue Bell
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Requirements:Must be located within the U.S.Must have 12+ months of independent monitoring experience as a CRAAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better
Reference
JR119530
Expiry date
01/01/0001
Author
Sarah WoodAuthor
Sarah WoodSalary
Location
Brazil
Department
Clinical Monitoring
Location
Brazil
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity. You
Reference
2024-110175
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Clinical Research Associate 1 you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2024-109834
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Denmark
Department
Clinical Monitoring
Location
Denmark
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Site Care Partner, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. In this role you will be the main point of con
Reference
2023-107467
Expiry date
01/01/0001
Author
Alison BurtonAuthor
Alison BurtonSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Reading
Department
Clinical Monitoring
Location
Reading
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
We are recruiting experienced UK-based Senior CRAs who are looking for a developmental role - with a strong ability to build relationships at site (involved in problem solving and data review). You w
Reference
2024-110167
Expiry date
01/01/0001