Senior Regulatory Affairs Specialist

Regulatory Scientist - Hybrid

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Sr. Regulatory Affairs Specialist to join our diverse and dynamic team. As a Sr. Regulatory Affairs Specialist at ICON, you will complete country and/or regional Clinical Trial Regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with sound scientific/technical principles in line with contractual agreement.

Depending upon experience, become involved, when required, staff training/mentoring and contribute to the review of ICON systems and procedures as appropriate

 

What you will be doing:

 

• Input to strategic planning of submissions to RA (DDCM and DEEC), and other country-level bodies, including proactive identification and mitigation of risks, as applicable.
• Direct interaction with regulatory authorities (mainly ANVISA) and other country-level bodies.
• Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation (DDCM and DEEC) according to applicable requirements.
• Arrange internal/external review of submission/documentation according to project requirements.
• Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered.
• Perform translation management according to project requirements.
• Collaborate with other roles in-country/region to meet ICON’s deliverables.
• Ensure all project-specific training is completed on time, as applicable.
• Adhere to study budget and proactively identifies out of scope activities.
• Support the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence.
• May mentor junior team members.
• May contribute to the review of ICON systems and procedures as appropriate.

 

Your profile:

 

• 4+ years of experience in clinical trial submissions.
• Experience 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.
• Advanced knowledge of country/region Regulatory Agency (RA) and other country-level authority clinical trial requirements, as applicable.

• Read, write and speak fluent English.

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply