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Company

GatedTalent - Connecting Top Executive Search Firms And Executives · 1 day ago

Remote Head of Regulatory Affairs Israel

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

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Responsibilities

Plan, direct, and monitor regulatory affairs activities so we have the permits, licenses, certificates, authorizations, and other approvals needed to conduct our business activities; and produce its goods and services.

Dossier creation, submission and registration

Life cycle management of regulatory files

Ensure promotional material complies with regulatory guidelines

Manage external vendors

Support development of roles and work processes.

Oversee development of plans, cost estimates, and schedules. Acquire the necessary permits and approvals.

Monitor regulatory developments and advise management on the potential impact of regulations on our organization.

Establish and maintain relationships with government agencies and other regulatory authorities.

Represent us in matters before regulatory, legislative, or industry standards agencies so our interests are advanced.

Prepare materials for legal counsel or external consultants.

Create and compile of registration application documentation.

Regulatory system, data entry and maintenance in/of regulatory systems.

Collaborate with the Ministry of Health

You will report to the Regional Regulatory Cluster Lead

Qualification

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Registered PharmacistRegulatory experiencePharmaceutical industryMatrix structuresCollaborative attitude

Required

Registered Pharmacist

Previous experience as appointed pharmacist

3+ years regulatory experience in the pharmaceutical industry

Experience in matrix structures

Collaborative with hands-on attitude

Company

GatedTalent - Connecting Top Executive Search Firms And Executives

GatedTalent was established in 2017 in response to the need for a secure and sophisticated tool to allow individual executives to share information privately with executive recruiters while supporting GDPR compliancy.

Founded in 2017

Basingstoke, Hampshire, GBR

51-200 employees