Director, Regulatory Affairs

Overview

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

Responsibilities

What you will be doing:

• Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams. In addition, responsibilities will include support to on-going clinical development activities. The candidate will contribute to and/or lead IND/CTA and BLA submissions activities for the client’s products in development and marketed products.    
• This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations, with a particular emphasis on US FDA regulations, governing pharmaceutical drug development of all aspects of the client’s quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.               
• Developing regulatory strategies for assigned programs in collaboration with the client's regulatory senior management and by analysis of guidance’s and assessment of drugs developed or precedent information available for similar indications to obtain approval of activities in support of the client's development and marketing objectives within specified timelines      
• Communicating with the FDA and other health authorities for assigned programs      
• Managing/leading regulatory activities associated with Regeneron-assigned drug development programs               
• Management of the planning, preparation and submission of Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)        
• Continually monitoring newly published FDA guidelines and international guidance documents in the context of the new and ongoing development programs           

Qualifications

You are:

• 10 years of pharmaceutical industry experience, at least 5 of which are in regulatory affairs 
• Strong background in Regulatory Affairs and a history of successful interactions with the Regulatory Agencies
• Candidate should have an M.D., Ph.D. or Pharm. D. degree or equivalent in work experience

What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.