Manager, Global Ethics Office – Policy Compliance
RTX
Senior Regulatory Associate, PM
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Remote • Maine, North Carolina, Rhode Island, Washington • 🇺🇸 United States
Visit company websiteSalary
💰 $47,000 - $79,900 per year
Job Level
Senior
About the role
- Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance.
- May also perform limited general project administrative duties.
- Responsibilities typically include creating and editing regulatory reports, summarization of data in the public domain, conduct quality control review of documents, and may also include collection and analysis of data to produce reports to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities.
- Prepares and submits full application or components of IND, marketing and lifecycle maintenance applications to ensure compliance with government acts and regulations.
- Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
- Unde
Requirements
- 3-5 years of Regulatory Experience within Industry
- BS/BA degree or equivalent practical experience
- Excellent interpersonal / communication skills
- Advanced skills in Microsoft Office Applications
- Strong analytical skills
- Ability to work independently and to understand and carry out detailed instructions
- Ability to interact with staff from multiple departments
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project
- Fluent in speaking, writing, and reading English.
- In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.
Benefits
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory submissionsregulatory compliancedata analysisquality controlreport writingIND applicationsNDA applicationsDMF submissionslifecycle maintenanceregulatory reporting
Soft skills
interpersonal skillscommunication skillsanalytical skillsindependent workattention to detailcollaborationtime managementadaptabilityproblem-solvinginstruction comprehension
