Associate Manager, Regulatory Affairs - Remote

Overview

The Associate Manager, Regulatory Affairs at BeOne is responsible for managing and coordinating regulatory projects to ensure timely submissions and compliance with regulatory requirements.

In Short

• Manage regulatory activities related to assigned projects.
• Plan and coordinate regulatory submissions.
• Provide guidance on regulatory strategy.
• Prepare and submit regulatory dossiers.
• Maintain compliance with regulatory requirements.
• Support project teams with regulatory expertise.
• Develop regulatory knowledge and advise management.
• Collaborate with external regulatory consultants.
• Work in a fast-paced and collaborative environment.
• Contribute to the fight against cancer.

Requirements

• BA/BS in Health Science or related field.
• 4+ years of experience in the pharmaceutical industry.
• Strong project management skills.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Ability to work independently and as part of a team.
• Knowledge of regulatory submissions (INDs, BLAs, NDAs).
• Analytical thinking and data analysis skills.
• Commitment to continuous learning and improvement.
• Ability to embrace change and drive excellence.

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and wellness programs.
• Equity awards and employee stock purchase plan.
• Annual bonus plan eligibility.
• Collaborative and inclusive work culture.
• Opportunities for professional development.
• Commitment to diversity and equal opportunity.
• Support for reasonable accommodations in the application process.
• Global team with a mission to improve access to medicines.