At a Glance
- Tasks: Lead regulatory projects and collaborate with global teams to ensure compliant submissions.
- Company: Join ICON, a leading healthcare intelligence and clinical research organisation.
- Benefits: Enjoy competitive salary, health coverage, and career development opportunities.
- Other info: Inclusive workplace with a focus on employee wellbeing and growth.
- Why this job: Make a real impact in healthcare by accelerating drug and device development.
- Qualifications: Background in life sciences and project management skills required.
The predicted salary is between 50000 - 65000 £ per year.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients, and suppliers.
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
The Regulatory Project Manager collaborates with regional and global cross-functional teams to plan, prepare, and deliver compliant regulatory submissions, providing support to ensure all business deliverables are met. Working on this exclusive client partnership, the Regulatory Project Manager is responsible for project managing submission-related operational aspects.
- Creating and managing project plans for regulatory projects using input from key stakeholders.
- Leading and managing cross-functional submission teams from authoring to dispatch/project goal delivery.
- Identifying operational risks with projects/submissions, implementing mitigation plans, and managing issues to closure.
Responsibilities:
- Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals.
- Partners with document providers to project manage the timely receipt of submission-ready documents for inclusion in global dossiers.
- Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
- Ensures that the company is aware and responsive to external guidelines, regulations, changes in the marketplace, and other information relating to global regulatory project and submission management.
To enable success in this position you will have:
- A relevant educational background in a life-sciences discipline.
- Some previous experience in submissions, regulatory operations, or publishing.
- Strong project management skills.
- Fluency in English.
Need experience in:
- Microsoft Project (needed).
- Experience supporting BLA’s/IND’s.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits:
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.
Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility:
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Regulatory Project Manager employer: IRE
ICON plc is an exceptional employer, offering a dynamic work environment where integrity, collaboration, and inclusion are paramount. As a Regulatory Project Manager, you will benefit from a competitive salary, comprehensive health and wellbeing programmes, and robust career development opportunities, all while contributing to meaningful projects that advance healthcare. With a commitment to employee growth and a supportive culture, ICON is dedicated to ensuring that every team member feels valued and empowered in their role.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Project Manager
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like IRE. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like IRE.
✨Leverage Internships for Full-time Roles
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✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what IRE is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Project Manager
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at IRE!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show IRE that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at IRE!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At IRE, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at IRE
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at IRE that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with IRE’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
