Project Manager– Regulatory Affairs jobs in United States
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ClinChoice · 2 months ago

Project Manager– Regulatory Affairs

Clinchoice is a company focused on regulatory affairs, and they are seeking a Project Manager to oversee regulatory projects and ensure compliance with submission timelines. The role involves coordinating teams, maintaining documentation, and providing strategic advice based on project experiences.

BiotechnologyConsultingHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Assist in the planning and tracking of long-term regulatory projects and submission timelines
Regularly communicate with clients to understand their needs and proactively address them
Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met
Maintain accurate project documentation including project plans, timelines, and status reports
Drive regulatory updates and assist in assessing their impact on ongoing projects
Contribute to the development and improvement of regulatory project management processes and tools
Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team
Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution
Provide independent advice on the management of projects based on lessons learned and gained experience
Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team

Qualification

Regulatory operations project managementEnglish communicationProject documentation managementFlexibility to travelSelf-driven

Required

Having experience in managing regulatory operations projects as PM
Strong English communication is a must
Self-driven individual
Flexible to travel for long durations – to Armenia
Mid-level experience 8-10 years should be fine

Company

ClinChoice

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ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.

H1B Sponsorship

ClinChoice has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)

Funding

Current Stage
Late Stage
Total Funding
$212M
Key Investors
Legend CapitalGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C

Leadership Team

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John Balian, MD
Chief Executive Officer
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Company data provided by crunchbase