CONTRACT|Yerevan, Armenia · Հեռավար|Տեղադրված է 4/29/2026
ICON plc /Regulatory Submission Manager
Նկարագրություն
ICON plc is hiring a Regulatory Submission Manager in Yerevan, Armenia. ICON is a world-leading healthcare intelligence and clinical research organization. This contractor/subcontract role sits within ICON Strategic Solutions and focuses on regulatory affairs, drug development support, regulatory submissions, agency interactions, clinical trial applications, marketing applications, and post-approval regulatory activities. The role is remote and belongs to the Drug / Device Regulatory Affairs category.
Պարտականություններ
- Lead regulatory activities and submissions independently, including submissions such as CTA, IND, and MAA.
- Provide regulatory guidance and operational support to internal teams.
- Participate in agency interactions and regulatory submissions.
- Contribute to best practices within ICON Regulatory Affairs through knowledge of regulatory processes and guidelines.
- Work collaboratively as part of regulatory and cross-functional teams depending on project size and nature.
- Support drug development activities across early development, clinical trial applications, marketing applications, and post-approval regulatory work.
Պահանջներ
- Bachelor’s degree in a scientific or healthcare-related field.
- Advanced degree is preferred.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Prior experience with regulatory submissions such as CTA, IND, and MAA.
- Ability to lead internal teams and manage regulatory activities independently.
- Strong understanding of global regulatory requirements and guidelines.
- Strong collaboration skills for working with regulatory and cross-functional teams.
Հմտություններ
RegulatoryAffairsSubmissionsDrugDevelopmentClinicalTrialApplicationsCTAINDMAAAgencyInteractionsPharmaceuticalIndustryBiotechnologyGuidanceStrategyCross-functionalCollaborationGlobalRequirementsResearchHealthcareScientificDocumentation
ICON plc
ICON plc is a global clinical research organization (CRO) that provides consulting, clinical development, and commercialization services to the pharmaceutical, biotechnology, and medical device industries. The company supports the full lifecycle of drug development, including clinical trials, data analysis, regulatory support, and market access. ICON helps accelerate the development of new treatments through advanced analytics, technology, and scientific expertise.