Principal, Regulatory Consulting
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please click here to view live vacancies.
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post- marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.
Job Title: Principal, Regulatory Affairs, US
Location: Home or office based in any ICON’s US office location
Type: Full time, permanent
The Position:
The Principal, Regulatory Affairs has the responsibility for driving and developing the US regulatory business especially aimed at clients based inside the US whose interest is in filing with the FDA. The Director provides expert advice/strategy and opinion to clients within the US Regulatory environment. This position is a management, business and expert role.
Responsibilities:
Provide strategic direction and management for clients on US regulatory issues.
- Effectively oversee the preparation of regulatory submission documents in adherence with applicable Regulations and Directives for submission to government agencies (focus on the US).
- Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project team. Building positive working relationships with clients and government agency contacts.
- Review and/or create study reports, clinical protocols, safety and efficacy reports for accuracy and compliance to regulations. Review of draft submissions for regulatory content and the editorial viewpoint.
- Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Lead and participate in formal interactions (face-to-face meetings, teleconferences, etc.) with clients and government agencies. Build positive working relationships with clients and government agency contacts.
- Interact with potential clients to develop new business and create win-win agreements.
- Identify project issues and develop alternate strategies for presentation to client. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
- Participate in or conduct quote preparation and new project / client consultations.
- Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies.
- Present industry related training seminars or workshops at industry conferences.
- Participate in the planning and execution of the strategic direction for the US business.
Requirements:
- Significant experience of pharmaceutical / biologics development in the US regulatory environment, including leadership and/or senior consulting experience.
- Expert knowledge and understanding of the development process for pharmaceutical and Biological products including: CMC, non-Clinical and Clinical
- Working knowledge of venture capital and credit markets and their role in drug development
- Strong knowledge of a variety of computer programs including MS Office, Adobe Acrobat, and eCTD compiling software, EDMS systems
- Displays full knowledge of protocol, regulatory requirements, and company SOPs. Identifies, documents, and discusses protocol violations, regulatory non-compliance, and issues involving subject safety.
Education
- Advanced degree (M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Chemical or Engineering. BSc required.
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment. #
*LI-SB1
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
06/06/2025
Summary
Building Connections that Drive Progress In an industry where collaboration is critical to advancing science and improving patient outcomes, networking is more than a professional courtesy - it’s
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/29/2025
Summary
Blood Cancer Day Blood Cancer Day is a powerful reminder of the millions of individuals and families whose lives are affected by hematological malignancies every year. These diseases are complex,
.png)
Teaser label
IndustryContent type
BlogsPublish date
05/22/2025
Summary
World Schizophrenia Awareness Day 2025 Every year on 24 May, World Schizophrenia Awareness Day offers a vital opportunity to raise awareness, dismantle stigma, and celebrate the strength of individ
Similar jobs at ICON
Salary
Location
Mexico
Department
Clinical Operations Roles
Location
Mexico
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As an Associate Project manager at ICON, you will play a pivotal role in supporting the coordination and management of clinical trials, contributing to the design, analysis, and advancement of treatme
Reference
2025-120551
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Brazil
Department
Clinical Operations Roles
Location
Brazil
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Senior Investigator Pricing Analyst, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-120452
Expiry date
01/01/0001
Author
Bruna DuarteAuthor
Bruna DuarteSalary
Location
United States
Department
Clinical Operations Roles
Location
United States
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Contracts Administration
Job Type
Permanent
Description
Icon is looking for a Sr. Pricing Associate. This person will support Global Development Operations, Global Study and Clinical Management Groups, Therapeutic Area Teams, and Finance by: creation of pr
Reference
2025-120576
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
What you will be doing:As a Contract Negotiator, you will play an integral role in ensuring physicians at our research sites are prepared to initiate clinical trials of investigational pharmaceutical
Reference
JR128998
Expiry date
01/01/0001
Author
Diego ToniniAuthor
Diego ToniniSalary
Location
Brazil, Sao Paulo
Location
Sao Paulo
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Supplies
Job Type
Permanent
Description
We are currently seeking a Logistics Coordinator II to join our diverse and dynamic team. As a Logistics Coordinator II at ICON, you will play a crucial role in overseeing and optimizing logistics ope
Reference
JR132077
Expiry date
01/01/0001
Author
Florencia Borello TaianaAuthor
Florencia Borello TaianaSalary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Home-Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with th
Reference
2025-120487
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz