Confidentiel · 6 hours ago
Senior Director, Regulatory Affairs
California, United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$261K/yr - $289K/yr
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Hiring Manager
Jorge B.
Insider Connection @Confidentiel
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Responsibilities
Collaborate with development teams to establish regulatory strategies and plans, representing the regulatory function as a core contributor to development.
Supervise one or more regulatory affairs staff, providing mentorship and career development support.
Write and critically evaluate regulatory documents, mastering scientific and clinical content related to development and regulatory goals.
Keep management informed of the status and timelines of pending submissions and any relevant correspondence with regulatory authorities.
Work with multidisciplinary teams to manage the regulatory aspects of projects, ensuring alignment with project plans and timelines.
Develop and communicate regulatory strategies that align with project objectives and business goals.
Lead the execution of regulatory submission plans.
Identify potential risks in programs or submissions and implement mitigation strategies.
Coordinate regulatory meeting packages and lead meetings with regulatory authorities.
Oversee regulatory activities related to clinical trials.
Provide leadership to the regulatory team, offering guidance and support across the organization.
Manage external regulatory vendors and resources.
Advise on labeling, promotional reviews, and post-marketing/commercial regulatory activities.
Ensure compliance with regulatory reporting requirements.
Provide guidance on document management systems (e.g., Veeva) and assist new users as necessary.
Ensure that process and standards documents (e.g., SOPs, work instructions) related to regulatory activities are current and effective.
Serve as a Subject Matter Expert in inspection-readiness activities for assigned programs.
Stay updated on new regulatory developments and provide intelligence to the team.
Represent the company’s interests with national government agencies, industry associations, and other organizations influencing legislation, regulations, or guidelines.
Perform other duties as required.
Qualification
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Required
Experience in rare neuromuscular diseases
Establish regulatory strategies and oversee global regulatory activities for product registrations and approvals
Manage life cycle plans, regulatory submissions (INDs, BLAs, CTAs, MAAs, Amendments, PIPs, Designations, etc.)
Ensure regulatory compliance
Collaborate with development teams to establish regulatory strategies and plans
Supervise one or more regulatory affairs staff, providing mentorship and career development support
Write and critically evaluate regulatory documents, mastering scientific and clinical content related to development and regulatory goals
Keep management informed of the status and timelines of pending submissions and any relevant correspondence with regulatory authorities
Work with multidisciplinary teams to manage the regulatory aspects of projects
Develop and communicate regulatory strategies that align with project objectives and business goals
Lead the execution of regulatory submission plans
Identify potential risks in programs or submissions and implement mitigation strategies
Coordinate regulatory meeting packages and lead meetings with regulatory authorities
Oversee regulatory activities related to clinical trials
Provide leadership to the regulatory team, offering guidance and support across the organization
Manage external regulatory vendors and resources
Advise on labeling, promotional reviews, and post-marketing/commercial regulatory activities
Ensure compliance with regulatory reporting requirements
Provide guidance on document management systems (e.g., Veeva) and assist new users as necessary
Ensure that process and standards documents (e.g., SOPs, work instructions) related to regulatory activities are current and effective
Serve as a Subject Matter Expert in inspection-readiness activities for assigned programs
Stay updated on new regulatory developments and provide intelligence to the team
Represent the company’s interests with national government agencies, industry associations, and other organizations influencing legislation, regulations, or guidelines
Company
Confidentiel
201-500 employeesFunding
Current Stage
Growth StageCompany data provided by crunchbase
