Planet Pharma
Director of Regulatory Operations
Planet Pharma, Redwood City, California, United States, 94061
Job Description
The Opportunity:
The Director of Regulatory Operations will be responsible for developing and scaling a regulatory infrastructure that supports growth and increased portfolio complexity. This position offers the opportunity to build upon an established team and function by implementing the systems, processes, and practices required for long-term scalability and compliance. Reporting to the Senior Director of Regulatory Operations, this individual will support the strategic direction of Regulatory Operations, conduct a thorough analysis of current capabilities, and manage the development and implementation of operational improvements. The role will also provide mentorship to a capable team currently managing health authority submissions and ready for expanded responsibilities. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve. Define strategic plans and ensure efficient operational execution with leadership to support increasing submission volume, expansion, and company growth.
Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of scale.
Advance cross-functional initiatives that enhance the department's strategic impact and operational effectiveness and provide value to the overall positioning of the department
Translate business needs into scalable, well-documented regulatory systems and process configurations.
Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations.
Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers.
Mentor a team towards exceptional performance, while coordinating with external vendors to ensure timely, high-quality regulatory publishing.
Support the system owner and administrator for regulatory technologies (e.g., Veeva Vault RIM); manage implementations, upgrades, and change management activities.
Champion the adoption of innovative tools and technologies to improve submission operations, regulatory compliance, and organizational scalability cross-functionally. Required Skills, Experience and Education:
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. Preferred Skills:
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Opportunity:
The Director of Regulatory Operations will be responsible for developing and scaling a regulatory infrastructure that supports growth and increased portfolio complexity. This position offers the opportunity to build upon an established team and function by implementing the systems, processes, and practices required for long-term scalability and compliance. Reporting to the Senior Director of Regulatory Operations, this individual will support the strategic direction of Regulatory Operations, conduct a thorough analysis of current capabilities, and manage the development and implementation of operational improvements. The role will also provide mentorship to a capable team currently managing health authority submissions and ready for expanded responsibilities. Success in this role requires the ability to execute while building, work effectively in a dynamic and highly collaborative environment, and remain flexible and adaptive as priorities evolve. Define strategic plans and ensure efficient operational execution with leadership to support increasing submission volume, expansion, and company growth.
Communicate complex regulatory and operational issues clearly, providing solutions that balance compliance with the demands of scale.
Advance cross-functional initiatives that enhance the department's strategic impact and operational effectiveness and provide value to the overall positioning of the department
Translate business needs into scalable, well-documented regulatory systems and process configurations.
Drive the development, optimization, and implementation of procedures, training, and documentation to support compliant and efficient submission operations.
Provide oversight for teams responsible for planning, preparing, publishing, submitting, and archiving global regulatory dossiers.
Mentor a team towards exceptional performance, while coordinating with external vendors to ensure timely, high-quality regulatory publishing.
Support the system owner and administrator for regulatory technologies (e.g., Veeva Vault RIM); manage implementations, upgrades, and change management activities.
Champion the adoption of innovative tools and technologies to improve submission operations, regulatory compliance, and organizational scalability cross-functionally. Required Skills, Experience and Education:
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. Preferred Skills:
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.