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- Tasks: Lead regulatory projects and client interactions while managing submissions and timelines.
- Company: Join ICON plc, a top-tier healthcare intelligence and clinical research organisation.
- Benefits: Enjoy flexible work options, competitive salary, health insurance, and various well-being perks.
- Why this job: Be part of a diverse team shaping the future of drug development with impactful work.
- Qualifications: Bachelor's degree in a scientific field; 6+ years in regulatory affairs or project management required.
- Other info: Remote role available in Poland, Bulgaria, or the UK; inclusive culture prioritising diversity.
The predicted salary is between 36000 - 60000 £ per year.
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 Regulatory Project Manager (RPM) to join our diverse and dynamic Regulatory Project Services (RPS) team. As an RPM at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Consulting Solutions (RCS) team. You will provide Project Management and regulatory support across various stages of the project lifecycle, including early/late development, agency interactions, initial and marketing applications, and post-approval activities.
What you will be doing:
- Lead client engagements and interactions, developing professional internal and external communications.
- Lead regulatory activities and submissions, with prior experience in areas such as CTA/IND/NDA/MAA/Post Marketing and Life Cycle.
- Provide regulatory coordination and support to internal teams.
- Manage agency interactions and regulatory submissions by developing detailed timelines and convening appropriate resources.
- Manage projects to remain within budget and scope, while creating detailed plans to support the execution activities.
- Contribute to developing best practices within ICON RPS through your insight of regulatory processes and guidelines.
- Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature.
Your profile:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- Minimum of 6 years of experience in regulatory affairs or project management within the pharmaceutical or biotechnology industry.
- Prior experience with various regulatory submissions, including CTA/IND/NDA/MAA/Post Marketing and Life Cycle.
- Ability to lead internal teams to execute upon regulatory strategy and client goals.
- Strong understanding of global regulatory requirements and guidelines.
- Understanding of eCTD structure and high-level global publishing approaches.
- Experience with Project Management tools such as MS Project and OnePager.
- Project Management Professional (PMP) and/or Regulatory Affairs Certification (RAC) or similar accreditation a plus.
What ICON can offer you:
- 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.
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.
Manager, Regulatory Project Services employer: ICON plc
Contact Detail:
ICON plc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Regulatory Project Services
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks relevant to the pharmaceutical and biotechnology industries. Understanding the nuances of CTA, IND, NDA, and MAA submissions will give you a significant edge in discussions during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry conferences or webinars where you can meet current employees from ICON or similar organisations. This can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Brush up on your project management skills, especially with tools like MS Project and OnePager. Being able to demonstrate your proficiency in managing timelines and resources effectively will show that you are well-prepared for the role.
✨Tip Number 4
Prepare to discuss your experience with agency interactions and regulatory submissions in detail. Be ready to share specific examples of how you've successfully navigated these processes in past roles, as this will highlight your expertise and readiness for the position.
We think you need these skills to ace Manager, Regulatory Project Services
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and project management. Emphasise your familiarity with various regulatory submissions like CTA, IND, NDA, and MAA, as well as any leadership roles you've held.
Craft a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Mention specific projects or experiences that align with the responsibilities of the Regulatory Project Manager position, showcasing your ability to lead client engagements and manage agency interactions.
Highlight Relevant Skills: Clearly outline your skills related to project management tools such as MS Project and OnePager. Also, mention any certifications like PMP or RAC that demonstrate your commitment to the field and enhance your application.
Showcase Team Collaboration: Provide examples of how you've successfully worked within cross-functional teams. Highlight your ability to coordinate with internal teams and manage projects effectively, ensuring you stay within budget and scope.
How to prepare for a job interview at ICON plc
✨Understand Regulatory Frameworks
Familiarise yourself with the key regulatory frameworks relevant to the pharmaceutical and biotechnology industries. Be prepared to discuss your experience with submissions like CTA, IND, NDA, and MAA, as well as how you have navigated these processes in past roles.
✨Showcase Project Management Skills
Highlight your project management experience, especially with tools like MS Project and OnePager. Be ready to provide examples of how you've managed timelines, budgets, and resources effectively in previous projects.
✨Demonstrate Leadership Abilities
As a Regulatory Project Manager, you'll need to lead teams and client engagements. Prepare to share specific instances where you've successfully led a team or project, focusing on your communication and coordination skills.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities in regulatory affairs. Think about challenges you've faced in past roles and how you overcame them, particularly in relation to agency interactions and regulatory submissions.
