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Summary
About the Role
About You
- Proven leadership in developing and executing regulatory operations strategy within global biotech or biopharma organizations.
- Deep expertise in submission planning, global regulatory frameworks, eCTD standards, and Health Authority requirements.
- Advanced experience managing and configuring regulatory systems, particularly Veeva Vault RIM.
- Strong project management skills, with the ability to oversee multiple priorities and deliver results in a dynamic environment.
- Clear and persuasive communicator across technical and business stakeholders.
- Effective collaborator with the ability to influence and align cross-functional teams.
- Strategic thinker with a practical problem-solving mindset and long-term business orientation.
- Committed to developing high-performing teams and fostering a culture of accountability and continuous improvement.
- Experience leading process improvement and system optimization initiatives in a compliance-focused environment.
- Seasoned people manager.
- Adept in regulatory publishing; capable of serving as a backup publisher.
- Proficient in Smartsheet for project tracking and collaboration.
- Proficient in Lorenz DocuBridge.
- Extensive hands-on experience with Veeva RIM system management.
Benefits
- Competitive hourly rate ranging from $100 to $150.
- Opportunity to work in a dynamic and collaborative environment.
Founded in 2012, Planet Pharma has a dedicated team of seasoned professionals with extensive experience supporting the Life Sciences industry, specifically: - Pharmaceuticals - Biotechnology - Medical Device & Diagnostics - Clinical Research Organizations (CROs) - CMOs / CDMOs - Specialty Providers - Labs & Healthcare Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent — ultimately making staffing more personal and creating enduring, valuable relationships. We achieve this by leveraging cutting-edge technology and flexible service delivery models that enable us to provide personalized solutions for your business. Planet Pharma has offices throughout North America, Europe, and APAC. All locations operate with shared attributes at the heart of everything we do! We provide the following solutions: - Contract & Direct Hire (Permanent) Staffing - Strategic Resourcing - Retained & Executive Search - Functional Service Provider (FSP) - Global Workforce Solutions