Director, Regulatory Affairs - (Biologics)
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please click here to view live vacancies.
Director, Regulatory Affairs
Location: Any location in the US. Remote or Office based.
Due to a number of exciting new projects being awarded to ICON, we are seeking to expand our team and expertise, with the recruitment of a Director of Regulatory Affairs within our US team. We are looking for passionate, resilient, and inspiring individuals to join our Strategic Regulatory Affairs (SRS) team. SRS are a global team of regulatory strategists from pharma, CRO and agency backgrounds, with expertise in drug development, regulatory strategy and operational implementation. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services
As a Director, Regulatory Affairs, you will create a culture of, process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs. Representing ICON as a Subject Matter Expert for Regulatory Affairs in the US market you will proactively communicate objectives and results with clients offering strategic regulatory advice.
In this role, you will be responsible for regulatory strategy for a combination of current and prospective clients in the US for drugs and biologics. As a senior member of the SRS team, you will further be responsible for the strategic approach and client interactions necessary to securing new and repeat business, facilitating issue resolution and ensuring project/program timelines/budgets are met. You will also maintain client relationships in the support of future business as the position participates in business development activities.
Responsibilities and accountabilities:
Actively anticipate, develop and implement initial or alternative regulatory strategies for contracted clients.
Act as scientific thought leader for ICON. Support initiatives to ensure ICON is at the leading edge of new regulatory developments e.g. DCT, COVID-19, GMO, ATMP development, Cell and Gene therapy etc.
Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise, consulting with other resources within the organization as required.
Manage workflow including prioritizing project objectives, and establishing timeframes for projects with clients and managing client contracts.
Effectively prioritize and complete multiple projects within established timeframes and within budget
Train, coach, and develop assigned individuals to build overall team expertise
Develop and implement strategies and regulatory submissions for PIP, OD, SME, MAA and post-licensing activities as applicable.
Function as primary liaison with FDA for designated projects and designated clients
Conceptualize and draft complete proposals based on a client idea or (Request for Proposal (RFP) including Independent development of project plans and scientific content for clients. Achieve a good conversion rate of submitted to won proposals.
Act as scientific thought partner with the client and the project team throughout the project.
May lead a team
Knowledge/Skills/Attributes
Leading FDA pre -IND, End of Phase 2 and Pre NDA/BLA meetings with FDA.
Experience with small molecules, biologics, gene therapy and cell therapies.
Post market support experience
Excellent verbal and written communication: Conveys thoughts in a clear, concise, and accurate manner. Uses appropriate regulatory, medical, and scientific nomenclature. Listens carefully and asks questions when necessary to ensure understanding
Planning and organization: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively.
Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
Experience in client interaction and/or in a consulting environment is advantageous
Experience in regulatory writing, meeting packages, dossiers
Education/ Experience:
Bachelor's degree in a relevant discipline, preferably in 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.
Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on US Regulatory Affairs
Experience supporting client development activities and people management.
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
Japan, Tokyo
Department
Full Service - Development & Commercialisation Solutions
Location
Tokyo
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
Job Advert PostingWe are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at ICON, you will be responsible for leading and coordinating project activities
Reference
JR127165
Expiry date
01/01/0001
Author
Mai TakanashiAuthor
Mai TakanashiSalary
Location
Japan, Tokyo
Location
Osaka
Tokyo
Remote Working
Home or Office
Business Area
ICON Full Service & Corporate Support
Job Categories
Drug / Device Regulatory Affairs
Job Type
Permanent
Description
We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic team. As a Senior Manager, Regulatory Affairs at ICON, you will play a pivotal role in designing and analy
Reference
JR127715
Expiry date
01/01/0001
Author
Haruna YamabayashiAuthor
Haruna YamabayashiSalary
Location
India, Chennai
Department
Full Service - Corporate Support
Location
Chennai
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Accounting & Finance
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
JR129280
Expiry date
01/01/0001
Author
Puja JaiswalAuthor
Puja JaiswalSalary
Location
Shanghai
Department
Clinical Monitoring
Location
Shanghai
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a CRA1 you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-120017
Expiry date
01/01/0001
Author
Irena GuoAuthor
Irena GuoSalary
Location
Mexico
Department
Clinical Trial Management
Location
Mexico
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As Manager Clinical Operations, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be part of an innovative and
Reference
2025-119958
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
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
Reference
2025-118789
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie Pruitt