Regulatory Writing Manager, Biopharmaceutics - Remote (JP12795)

Overview

The Regulatory Writing Manager will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards for a leading global biotechnology company.

In Short

• Write clinical study reports and Investigator Brochures.
• Prepare CTD sections and other regulatory submission documents.
• Lead study timelines and regulatory submission strategy.
• Ensure quality of regulatory documents.
• Provide expertise and mentorship on document design.
• Participate in departmental meetings and initiatives.
• Assist with hiring and resourcing therapeutic areas.
• Act as a functional area representative on product teams.
• Work in a collaborative environment.
• Engage in negotiation and analytical judgment.

Requirements

• 3-5 years of experience with clinical content documents.
• Masters or higher degree in a scientific field.
• 5+ years in writing clinical and regulatory documents.
• Ability to analyze medical data.
• Knowledge of regulatory guidance (e.g., ICH).
• Strong written and oral communication skills.
• Leadership skills in a collaborative team environment.
• Project management skills.
• Attention to detail.
• Ability to operate in a negotiation and collaboration environment.

Benefits

• Fully remote work opportunity.
• Flexible working hours (approximately 30 hours per week).
• Engagement with a leading biotechnology company.
• Opportunity for contract extension.
• Collaboration with experienced professionals.
• Mentorship opportunities.
• Involvement in significant regulatory projects.
• Professional development in regulatory writing.
• Networking opportunities in the biotechnology field.
• Competitive hourly rate.