Project Manager/Senior Manager, Regulatory Affairs - Remote

Overview

We are seeking a detail-oriented and proactive Project Manager/Senior Manager, Regulatory Affairs, to join our pharmaceutical team. This role will involve leading and managing regulatory activities to support product development, approval, and post-marketing compliance.

In Short

• Develop, implement, and manage regulatory strategies for global submissions.
• Monitor and interpret global regulatory guidelines.
• Oversee preparation and submission of regulatory filings.
• Manage timelines for CMC, Clinical, and Nonclinical Modules.
• Track submission deliverables and manage workflows.
• Collaborate with cross-functional teams.
• Lead program activities and conduct risk assessments.
• Communicate program status to stakeholders.
• Provide PM support for meetings with regulatory agencies.
• Ensure compliance for internal and external audits.

Requirements

• Bachelor’s degree in life sciences, pharmacy, or related field.
• 5+ years of experience in regulatory affairs.
• Comprehensive understanding of global regulatory requirements.
• Strong project management skills.
• Excellent written and verbal communication skills.
• Proficiency in MS Office Suite and project management tools.
• Strong analytical and problem-solving skills.
• Attention to detail and commitment to quality.
• Ability to work collaboratively in a team-oriented environment.
• Leadership and mentoring abilities.

Benefits

• Patient Days to learn from individuals living with conditions.
• A culture inspired by values: put patients first, think independently.
• Access to learning and development resources.
• Robust and market-competitive compensation & benefits package.
• Flexible PTO.
• Rapid career advancement for strong performers.
• Commitment to Diversity, Equity & Inclusion.