Senior Global Regulatory Affairs Specialist

Sr Global Reg Affairs Scientist - PHL/MY - Homebased

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are currently seeking a Senior Global Regulatory Scientist to join our diverse and dynamic team. The Senior Global Regulatory Scientist fulfils the role of Global Regulatory Partner (GRP) and is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met.

What you will be doing:

• Ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles

• Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable

• Regulatory function team lead overseeing the assigned clinical trial Regulatory project team

• Point of contact for clients for clinical trial Regulatory deliverables

• Preparation of clinical trial Regulatory plan in accordance with project specifications

• Preparation/creation/adaptation/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in addition to study requirements

• Tracking and reporting of submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents

• Performing Quality Control review of clinical trial Regulatory deliverables in accordance with applicable process

• Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and all other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team

• Coordination of clinical trial label review/approval according to project specifications

• Managing Regulatory study budget, proactively identifying out of scope activities and supporting budget recognition

• Supporting the maintenance of accurate, up to date Country and Regulatory Intelligence

• May work with Regulatory team members to provide Regulatory consulting services

• May participate in business development activities

• May mentor junior team members

Your profile:

• Bachelor's degree in a scientific discipline or related field.

  • Minimum of 3 years of experience in regulatory affairs submissions within the clinical research industry.

  • Demonstrates complete understanding and application of clinical research regulations, concepts and standards.

    • Strong understanding of global regulatory requirements and guidelines.

    • Demonstrates a good understanding of country requirements and how they need to be applied in the clinical trial environment.

    • Proven history of successful interaction with internal and client teams and a basic understanding of each related function

      • Excellent English communication and social skills.

        • Ability to work independently and collaboratively in a fast-paced environment.

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.

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, color, 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 or submit a request here

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