[Remote] Regulatory Affairs Project Manager, US Remote

Note: The job is a remote job and is open to candidates in USA. reputed company is seeking a seasoned Project Manager with experience in the regulatory space. This role is accountable for managing budgets, timelines, and quality guidelines for projects while ensuring that expectations are met and risks are identified and mitigated.

Responsibilities

• Evaluate the impact of clinical/regulatory changes on assigned projects as well as reputed company business operations
• Manage the preparation of high-quality submissions (or parts of submissions) to regulatory authorities pre and post marketing approval reputed company project timelines
• Manage the preparation of high-quality responses to RFP/RFI
• Monitor project schedule and scope to ensure both remain on track. Implement and follow preapproved procedures for any deviations
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to both reputed company and client requirements
• Propose and implement improvements to enhance the efficiency and the quality of the work performed on assigned projects
• Define and manage project resource needs and establish succession plans for key resources
• Create required project plans. Implement and monitor reputed company against project plans and revise as necessary
• reputed company other duties as assigned by management

Skills

• University/college degree (life science preferred) or certification in a reputed company allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. reputed company may consider relevant and equivalent experience in lieu of educational requirements
• Understanding of, and ability to determine relevance of, governmental regulatory processes and regulations as pertains to drug regulation
• Detailed knowledge of financial control procedures (i.e. costing systems, time reporting)
• Working knowledge of project management processes, especially as it relates to clinical development
• Working knowledge of time and cost estimate development
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
• Broad knowledge of drug development process and client needs
• Fluent in local office language and in English, both written and verbal
• At least 7 years of experience in the pharmaceutical industry with 5 years preferably in Regulatory Affairs or in Drug Development
• Demonstrated skills and competency in project management tasks and ability to work independently
• Financial awareness and ability to actively utilize financial tracking systems
• Master's or other advanced degree a plus
• PMP certification a plus

Benefits

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(K)
• Paid time off (PTO) or Flexible time off (FTO)
• Company bonus where applicable

Company Overview

Company H1B Sponsorship