Director, Regulatory Affairs
About the role
This vacancy has now expired. Please see similar roles below...
Director Regulatory Affairs
Location: Dublin, Ireland or London, UK (will also consider flexible remote based in EU)
ICON plc, a leading Clinical Research Organisation, employing 14,500 people across 97 offices in 38 countries - our mission is to help our clients to accelerate the development of drugs and devices that save lives and improve the quality of life!
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, CMC and quality assurance. We deliver global strategic regulatory consulting, dossier management services and GMP Quality services. As the Director Regulatory Affairs International, you will be responsible for the oversight of the Strategic Regulatory Services (SRS) International Regulatory team who focus on provision of strategic consulting activities outside of USA and Canada and for growth and development of the team through business development activities.
In this role you will lead the team and also lead regulatory strategy for some clients to support registration (new and maintenance) in Europe and Internationally for drugs and biologics, and be responsible for the strategic approach to securing new business, facilitating issue resolution, 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:
- Manage and oversee the SRS International Regulatory team
- Serve as a resource for SRS team members and ICON colleagues, providing advice on project and Regulatory strategies
- Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organisation as required. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise
- Responsible for managing team workflow including prioritising 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
- Effectively prioritise and complete multiple projects within established timeframes and within budget
- Train, coach, and develop assigned individuals to build team expertise
- Enthusiastically monitor for new regulatory requirements and share key findings
- Lead preparation of quotations for potential projects that may cross multiple service areas within the company
- Manage assigned projects within budget, preparing change orders as needed
- Provide thought leadership, speak at conferences and webinars, as appropriate
Knowledge/Skills/Attributes
- Thorough working knowledge of local and global Health Authority regulations, guidelines, policies, GCP and GxP, ICH Guidelines
- Effective project management skills
- Ability to make decisions independently and operate autonomously
- Sound listening, conflict management, and negotiating skills
- Excellent planning, organisation, interpersonal, time, and change management skills
- Demonstrable good problem solving, judgement, and decision-making skills to motivate staff to seek creative solutions to issues surrounding timely, on-budget, and quality delivery. Focuses on resolving problems and makes decisions in a timely manner
- Ability to develop and maintain excellent rapport with clients
- Highly motivated and proactive
- Through knowledge of budgetary and financial management (budget, development, time and cost, forecasting, revenue, margin, profit and loss, invoicing, etc.)
- Knowledge of business development process
- Shown ability to understand and communicate corporate policies and procedures
- 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
- Problem solving skills balanced with an awareness of business objectives. Good judgement in the face of difficult and clear situations
- Planning and organisation: Plans work effectively to meet goals and ensure timely completion of assignments. Manages time effectively. Has a routine or system for completing work
- Attention to detail: Identifies and resolves discrepancies across various source documents, including published and unpublished documents. Notes and resolves errors in written documentation
- Proficiency in all MS-Office applications, including Word, Excel, Powerpoint
Education/Experience
- Bachelor's 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.
- Minimum of 12-15 years related experience in Regulatory Affairs setting, in Pharma or CRO, with emphasis on EU and International Regulatory Affairs
- Experience supporting business development activities and people management.
- Experience presenting at applicable industry conferences and/or publications in regulatory affairs.
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
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
Shanghai
Department
Clinical Monitoring
Location
Shanghai
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Global Study Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Global Study Associate Shanghai Office based
Reference
2024-110204
Expiry date
01/01/0001
Salary
Location
Shanghai
Department
Clinical Monitoring
Location
Shanghai
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Global Study Associate Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Global Study Associate Manager Shang
Reference
2024-110203
Expiry date
01/01/0001
Salary
Location
Mexico, Mexico City
Department
Drug Safety & Pharmacovigilence
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Clinical Supplies
Job Type
Permanent
Description
Clinical Supplies Project ManagerICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced s
Reference
JR116640
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth DaviesSalary
Location
Ireland, Europe, United Kingdom, South Africa, Poland, Bulgaria, Spain, Germany, Netherlands, Romania, Czech Republic, Slovakia
Department
Biometrics Roles
Location
Any EMEA Location
Bulgaria
Czech Republic
Germany
Ireland
Netherlands
Poland
Romania
South Africa
Spain
UK
Slovakia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Statistics
Job Type
Permanent
Description
As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2023-104906
Expiry date
01/01/0001
Salary
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
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager 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
2023-103323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio Sanquiz