Regulatory Affairs Manager

Foster, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Foster City CA

Contract Duration: 5-36 months

Rate: Negotiable

Responsibilities:

Excellent employment opportunity for a Regulatory Affairs Manager in the Foster City CA area. Hybrid
Seeking a seasoned PRC Submission Management Lead to support the CPC team.
This specialized role requires deep expertise in the Medical Legal and Regulatory (MLR) review and approval process with a strong operational focus.
The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Serve as a Subject Matter Expert (SME) in US CPC team ensuring compliance with regulatory standards and internal processes.
Manage end-to-end MLR review cycles including submission preparation routing and tracking through Veeva Vault.
Attend PRC meetings to represent submission status clarify content and capture feedback.
Triaging and managing review comments from MLR teams including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure.
Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness.
Provide training and guidance to CPC team members on regulatory guidelines and best practices.
Develop a playbook outlining optimal ways of working across PRC and CPC teams.
Collaborate with Gileads AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.

Experience:

Required Years of Experience: 6-8 years
Proven experience in US Commercial Regulatory Affairs specifically within PRC/MLR review operations.
Strong working knowledge of Veeva Vault including digital asset submission routing and tracking.
Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams.
Experience working with agencies and internal content teams to resolve feedback and ensure compliance.
Operational mindset with the ability to streamline processes identify gaps and implement best practices.
Prior experience in training and documentation development is a plus.
Familiarity with AI applications in regulatory or marketing contexts is a bonus.
Top 3 Required Skill Sets:
- Experience in Medical Legal and Regulatory (MLR) review process
- Proficiency in Veeva Vault PromoMats
- Project Management and workflow optimization
Top 3 Nice to Have Skill Sets:
- Documentation and process mindset
- Change Management
- Familiarity with AI
Required Degree or Certification
Veeva Vault Certification or Training demonstrating proficiency in the platform
Project Management Certification (e.g. PMP) helpful for managing review cycles and cross-functional coordination

Foster City CA Contract Duration: 5-36 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Regulatory Affairs Manager in the Foster City CA area. Hybrid Seeking a seasoned PRC Submission Management Lead to support the CPC team. This specialized role requires deep...

Foster City CA

Contract Duration: 5-36 months

Rate: Negotiable

Responsibilities:

Excellent employment opportunity for a Regulatory Affairs Manager in the Foster City CA area. Hybrid
Seeking a seasoned PRC Submission Management Lead to support the CPC team.
This specialized role requires deep expertise in the Medical Legal and Regulatory (MLR) review and approval process with a strong operational focus.
The ideal candidate will have hands-on experience managing digital submissions in Veeva Vault and be comfortable navigating the complexities of PRC workflows.
Serve as a Subject Matter Expert (SME) in US CPC team ensuring compliance with regulatory standards and internal processes.
Manage end-to-end MLR review cycles including submission preparation routing and tracking through Veeva Vault.
Attend PRC meetings to represent submission status clarify content and capture feedback.
Triaging and managing review comments from MLR teams including coordinating re-review cycles and working closely with agencies or the Content Production Center (CPC) to ensure timely closure.
Conduct reference checks prior to PRC submission/routing to ensure accuracy and completeness.
Provide training and guidance to CPC team members on regulatory guidelines and best practices.
Develop a playbook outlining optimal ways of working across PRC and CPC teams.
Collaborate with Gileads AI team to advise on considerations for developing AI agents that support marketing content creation and regulatory fact-checking.

Experience:

Required Years of Experience: 6-8 years
Proven experience in US Commercial Regulatory Affairs specifically within PRC/MLR review operations.
Strong working knowledge of Veeva Vault including digital asset submission routing and tracking.
Demonstrated ability to manage complex review cycles and collaborate across cross-functional teams.
Experience working with agencies and internal content teams to resolve feedback and ensure compliance.
Operational mindset with the ability to streamline processes identify gaps and implement best practices.
Prior experience in training and documentation development is a plus.
Familiarity with AI applications in regulatory or marketing contexts is a bonus.
Top 3 Required Skill Sets:
- Experience in Medical Legal and Regulatory (MLR) review process
- Proficiency in Veeva Vault PromoMats
- Project Management and workflow optimization
Top 3 Nice to Have Skill Sets:
- Documentation and process mindset
- Change Management
- Familiarity with AI
Required Degree or Certification
Veeva Vault Certification or Training demonstrating proficiency in the platform
Project Management Certification (e.g. PMP) helpful for managing review cycles and cross-functional coordination