Senior Manager, Regulatory Affairs

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

What you will be doing:

• Participate in multidisciplinary project teams  to provide regulatory guidance and communicate regulatory goals.
• Provide guidance to teams on the content, format, style and architecture of IND, or CTAs (ex-US studies).
• Perform/manage critical analysis of data (clinical, preclinical and manufacturing) independently develop interpretations and conclusions. Perform reviews of clinical protocols and study reports to focus attention of deficient/missing items/explanations.   
• Accountable for ensuring the completeness and accuracy of all regulatory submissions
• Supervisory responsibility for planning, preparation and submission of regulatory documentation         
• Management of the planning, preparation and submission of Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)        
• Provide guidance/instruction to teams on the content, format, style architecture and timing of BLAs
• Assist with scientific writing and review of a BLA and evaluate conformance with regulatory requirements
• Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing developmental programs

You are:

• 4+ years of pharmaceutical industry experience 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/benefits

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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.