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Regulatory Specialist Sr
Job
Planet Pharma Group
Santa Clara, CA (In Person)
$91,520 Salary, Full-Time
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Job Description
We are seeking a highly driven and strategic Senior Regulatory Affairs Specialist to lead regulatory operations with a strong focus on global tender and regulatory affairs letters coordination and execution. This role is critical in ensuring timely, compliant, and high-quality regulatory deliverables to support international tenders, regulatory letters, and post-approval regulatory activities across multiple franchises. The ideal candidate operates with a high degree of independence, demonstrates strong cross-functional leadership, and can manage complex, multi-stakeholder deliverables with minimal oversight.
Key Responsibilities:
Tender Coordination & Execution- Lead and own end-to-end global tender regulatory deliverables, including regulatory documentation, certifications, and product compliance data
- Serve as the central point of accountability for tender-related regulatory activities across franchises
- Drive alignment and coordinate inputs across SMEs, including international affiliates, manufacturing, quality, packaging, R D, and labeling teams
- Develop and manage tender trackers, timelines, and governance structures to ensure visibility and on-time execution
- Identify risks, proactively escalate issues, and implement mitigation strategies to ensure tender success and timeliness
- Ensure compliance with regional and country-specific regulatory requirements Develop and monitor KPIs and dashboards to track performance and drive continuous improvement Regulatory Operations & Documentation
- Lead the review, coordination, and tracking of regulatory letters (LoA, PoA, controlled substance letters, evidence of conformance, etc)
- Executes preparation and submission of Certificates to Foreign Governments (CFGs), CFG-NE, COEs in the FDA database
- Provide oversight and quality review of Declarations of Conformity (DoC), DoC templates, and translations, ensuring compliance with MDR and global standards and regulations - Support translation requests through the translations portal - Review EU MDR DoC translations for accuracy and consistency
- Ensure adherence to Good Documentation Practices (GDP) across all deliverables
- Executes and tracks addendum labeling requests Cross-Functional Leadership
- Act as a key liaison between Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve complex regulatory challenges
- Facilitate cross-functional governance meetings and drive decision-making and accountability
- Influence stakeholders and align priorities across multiple functions and geographies Process Improvement & Governance
- Identify and implement process improvements and automation opportunities within regulatory operations and tender workflows
- Lead and support change management activities, including updates to procedures, templates, and systems
- Maintain and enhance trackers, SharePoint repositories, and documentation systems to improve efficiency Compliance & Issue Management
- Identify and address compliance risks and quality system gaps
- Support CAPA investigations and remediation activities
- Troubleshoot and resolve regulatory operational challenges impacting deliverables Qualifications & Skills
- Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions
- Strong experience managing complex, cross-functional initiatives independently
- Demonstrated expertise in global regulatory requirements (e.g., EU MDR, international markets)
- Advanced project management, prioritization, and organizational skills
- Excellent stakeholder management and influencing skills, including the ability to drive alignment without direct authority
- Strong critical thinking and problem-solving capabilities
- Ability to operate with minimal oversight and high accountability for outcomes