Technical Writer (Regulatory Affairs)

Regulatory affairs project role focused on submissions, project timelines, deliverable tracking, electronic submission tools, and FDA and global regulatory compliance.

Job Requirements

• Bachelor’s degree in Life Science or related field
• 3+ years of regulatory affairs experience
• Experience with regulatory submissions
• Experience with regulatory publishing
• 3+ years of project management experience
• Knowledge of FDA regulations
• Knowledge of global regulatory requirements
• Experience working with cross-functional teams
• Experience working with international teams
• Experience maintaining project databases
• Experience coordinating regulatory project timelines

Preferred Skills

• Project management experience in pharmaceutical or healthcare environments
• eCTD experience
• Experience using electronic submission tools
• Experience tracking regulatory milestones
• Experience tracking department metrics
• Experience supporting global regulatory submissions
• Experience managing incoming regulatory requests
• Experience reviewing documentation for quality and compliance

Job Responsibilities

• Coordinate regulatory submissions
• Manage regulatory project timelines
• Track deliverables, milestones, and department metrics
• Maintain project databases
• Manage incoming regulatory requests
• Support cross-functional teams during regulatory projects
• Support mitigation of resource conflicts
• Ensure compliance with FDA and international regulatory requirements
• Facilitate use of electronic submission tools
• Communicate across global teams
• Ensure regulatory documentation quality
• Support successful regulatory approvals through submission coordination and project tracking

Pay Details: $35.00 to $37.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.