Global Labeling Lead
As a Global Labelling Lead at ICON -you will shape and implement strategic regulatory labelling plans to the development and approval of innovative treatments within Plasma derived therapies
Position overview:The Global Regulatory Labeling Lead will play a key role in Global Labeling and works under the direction of the Head of Global Labeling and is:
• Responsible, with supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling
• Managing the preparation of strategic labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
• Developing regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
• Providing advice on current labeling requirements, templates, tools, and Health Authority issued guidance pertaining to pharmaceutical drug and device
You are:An experienced Labeling professional, keen to take the next step in your career.
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:
- An undergraduate degree in a relevant field of study
- Extensive experience and a proven track record of success in Regulatory Labeling
- Advanced knowledge of the scientific principles of the drug development process
- Advanced, broad knowledge of regulations pertaining to drug product labeling
- Excellent oral and written communication skills
- Excellent project management skills
- Excellent critical thinking skills
- Excellent attention to detail
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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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.
Are you a current ICON Employee? Please click here to apply
