At a Glance
- Tasks: Lead global teams in technical regulatory and quality for drug development.
- Company: Join ICON, a leading healthcare intelligence and clinical research organisation.
- Benefits: Competitive salary, health benefits, and career development opportunities.
- Other info: Inclusive culture focused on collaboration and continuous improvement.
- Why this job: Make a real impact in advancing patient care and shaping the future of healthcare.
- Qualifications: Expertise in regulatory CMC, Quality, and MDD with strong leadership skills.
The predicted salary is between 90000 - 110000 £ 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.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point.
Global Head, Technical Regulatory & Quality including Global Chemical Manufacturing & Controls, Quality and MDD Services:
- Provides global oversight and leadership to the teams supporting Chemistry, Manufacturing and Control (CMC), Quality and Medical Device & Diagnostic consulting services.
- Responsible for the strategic direction of the Technical regulatory CMC, Quality and MDD function, including driving business development strategies to grow and maintain the business with new and existing clients.
- Drives innovation by building the internal capability to position the organization as a leader of high-quality and differentiated service provision.
Responsibilities:
- Sets the vision and guides the achievement of goals.
- Translates high-level corporate strategy into long-range project plans to gain competitive advantage.
- Oversees the team services in the development and execution of Technical regulatory including Chemistry, Manufacturing and Control (CMC) and MDD development and registration strategies.
- Responsible for interpreting regulatory guidance in chemistry, pharmaceutical development, specifications, method development, manufacturing and validation.
- May act as CMC & Quality or MDD expert/representative for the supported organization if partnering with global health authorities.
- Leads evaluation of new business opportunities and actively involved in Bid Defense meetings.
- Identifies, leads, and sponsors regulatory technical initiatives.
- Embeds continuous improvement strategies for operational execution, quality and productivity gains.
- Manages and develops staff including staff professional development and project oversight accountability.
- Sets department strategy goals and objectives.
- Defines and tracks functional KPIs.
- Builds teams across functions and geographies with individuals who have the right technical, scientific and leadership skills.
- Develops capabilities and processes to expand business opportunities.
- Anticipates, identifies, assesses and prioritizes risks to business and client goals.
Qualifications:
- Expert understanding of scientific principles and regulatory technical CMC, Quality and MDD requirements relevant to global drug development.
- Expert knowledge of review and approval processes of applicable regulatory Health Authorities / Notified Bodies.
- Expertise in pharmaceutical drug and device development, product maintenance and global regulations.
- Ability to serve as lead in international Agency Interactions and product development meetings.
- Advanced leadership skills including change management, people development, strategic thinking and influencing.
- Excellent ability to plan, organize and deliver multiple or complex projects.
Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages and a range of health-related benefits to employees and their families.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you require reasonable accommodations during the recruitment process, please let us know.
Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) employer: IRE
ICON is an exceptional employer that prioritises integrity, collaboration, and inclusion, making it a fantastic place for professionals in the healthcare intelligence and clinical research field. With a strong commitment to employee wellbeing, ICON offers a competitive rewards package, comprehensive health programmes, and ample opportunities for career development, all while fostering a diverse and dynamic work culture. Whether working from home or in the office, employees are empowered to manage complex projects and contribute meaningfully to advancing patient-centric outcomes.
StudySmarter Expert Advice🤫
We think this is how you could land Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)
✨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.
✨Join Relevant Professional Bodies
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
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like IRE. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨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 Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)
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.
