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ICON plc · 3 days ago

Senior Manager, Regulatory Affairs - IVD

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

7+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Senior Manager, Regulatory Affairs to play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

Biotechnology

Responsibilities

Participate in provision of regulatory expertise in strategic drug development across multiple areas

Take part in preparation of strategic development and submission plans

Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and internally)

Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities

Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.)

Qualification

Regulatory affairs experienceRegulatory strategies developmentDocument writingMarketing authorization applicationsClinical trials experiencePost-licensing activitiesVerbal skillsPlanningOrganizingOrganizational skillsWritten skillsPresentation skillsProblem-solving abilityInterpersonal skills

Required

A minimum of 7 years regulatory affairs experience including supervisory experience and a minimum of 6 years pharmaceutical/CRO industry

Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction

Strong organizational skills, ability to manage multiple tasks, and meticulous attention to detail

Excellent written, verbal, and management skills, as well as demonstrated presentation skills, problem-solving ability, strong interpersonal skills, and the ability to plan/organize

Benefits

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.

Company

ICON plc

Glassdoor3.7

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

Founded in 1990

Dublin, IE

10001+ employees