Global Regulatory Lead

Global Regulatory Lead - Homebased in UK/Europe

As a Global Regulatory lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

An exciting new role with ICON within Our regulatory team dedicated to a leading biotechnology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer.

This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others.

Your primary areas of focus are to:

• Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally
• Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings
• Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
• Working with the rest of the regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested
• Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees
• Monitor, interpret, and communicate changes to the global regulatory landscape as required
• Serve as the regulatory affairs business partner to local commercialization teams
• Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
• Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams

You will have:

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA and EMA
• Prior experience working in rapidly growing pharmaceutical organizations is desirable
• A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines
• Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
• Affinity with science and ability to interact with scientists and clinicians
• Experience interacting with regulatory authorities, especially the FDA and EMA
• Ability to speak and interact with a diverse group of individuals on technical and business topics
• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, 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.

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.