Manager, Regulatory CMC (lifecycle management)

As a Manager, Regulatory CMC (lifecycle management) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are seeking 2 roles within our Regulatory CMC team

• CMC Life Cycle Management experience for Drug substance and Drug product is essential for this role.
• The position will involve planning and roll out
• strategic inputs for CMO addition
• VRIM expertise
• Change control assessment and regulatory planning, good to have facility knowledge.
• One will support Rare Endocrine portfolio of established products and the other Haemofilia established portfolio

What you will be doing:

• Plan, execute and manage regulatory submissions for assigned compounds or projects with appropriate supervision from RA CMC Management.
• Define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.
• Successfully communicate and negotiate with international subsidiaries and Health Authorities. Prepare meetings with Health Authorities and represent Regulatory Affairs CMC as necessary.
• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
• Collaborate with manufacturing sites to successfully compile required documentation.
• Interact with other internal and external colleagues, as well as with other functional areas and Alliance Partners.
• Evaluate change proposals for regulatory impact and filing requirements.
• Manage responses to letters of objections from Health Authorities for marketing authorization applications, product variations and renewals of international medicinal products.

You are:

Accurate, timeline-driven and passionate about science.

Here at Icon we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

• Previous experience working in regulatory CMC and compiling Module 3 documentation in a pharmaceutical environment
• A relevant educational background (preferably as a Chemist, Pharmacist or Biologist)
• The ability to understand, apply, and articulate regulatory CMC requirements for global drug development and post-market support initiatives, and assess the impact of change requests against regulatory guidelines
• Problem-solving ability, flexibility and team player
• Fluency in written and spoken English

We are open to considering candidates without previous CMC experience but who have instead a background in quality assurance, quality compliance or another area of regulatory affairs.

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.